Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)

Sponsor

Concordia Laboratories Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02082522

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

0.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is activated by a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lighting the abnormal areas using a fiber optic device (very fine fiber like a fishing line that permits light transmission) inserted into a flexible tube with a light called cholangioscope for the bile duct. The light will activate the porfimer sodium concentrated in the abnormal tissue, leading to its destruction.

This research study will evaluate the efficacy and safety of PDT with porfimer sodium administered with Standard Medical Care (SMC) compared to SMC alone on the overall survival time of patients with non-operable advanced cholangiocarcinoma, a rare cancer of the bile ducts. It will involve 200 patients across North America and Europe. Other countries may participate if needed. Participation will last at least 18 months.

Condition or Disease	Intervention/Treatment	Phase
Hilar Cholangiocarcinoma	Drug: Photodynamic therapy-Photofrin Procedure: Stenting procedure Drug: Chemotherapy regimen	Phase 3

Detailed Description

Cholangiocarcinoma (CCA) is defined as primary malignant tumors of the bile ducts. The exact etiology remains unknown. These cancerous tumors block the bile flow and can be intrahepatic (IH) or extrahepatic (EH). The distinction between IH- and EH-CCA has become increasingly important, as the epidemiological features (i.e., incidence and risk factors), the biologic and pathologic characteristics and the clinical course are largely different. Unfortunately, most subjects are found to have metastases or unresectable disease at the time of diagnosis. Median survival for subjects with unresectable perihilar-CCA varies between five and eight months. The one-year survival is 50%, with 20% surviving at two years and 10% at three years. Unresected CCA is a rapidly fatal process with cholangitis being a significant cause of morbidity and mortality in these subjects.

This study was designed to confirm the efficacy of PHOPDT + standard medical care (SMC) defined as stents plus gemcitabine/cisplatin chemotherapy regimen on the overall survival of subjects with unresectable cholestasis perihilar Bismuth type III or IV - tumor TNM stage III or IVa CCA.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Multicenter, Open-label, Randomized, Controlled Phase III Clinical Study of the Efficacy and Safety of Photodynamic Therapy Using Porfimer Sodium for Injection as Treatment for Unresectable Advanced Perihilar Cholangiocarcinoma

Actual Study Start Date :

Nov 12, 2014

Actual Primary Completion Date :

Jan 12, 2017

Actual Study Completion Date :

Jan 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Photodynamic therapy-Photofrin plus SMC Photodynamic therapy (PDT) involves the i.v. injection of Photofrin followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) will be applied to the tumor. A second light application will be given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients will undergo stenting as part of standard medical care procedure. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) may be given at 3-month intervals. Standard Medical Care (SMC) is defined as stenting procedure plus chemotherapy regimen.	Drug: Photodynamic therapy-Photofrin Photodynamic therapy (PDT) involves the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device during an endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC). Two days after the injection, a laser light (180 J/cm(2)) will be applied to the tumor. A second light application will be given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients will undergo stenting as part of standard medical care procedure. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) may be given at 3-month intervals. Other Names: PDT-Photofrin Procedure: Stenting procedure As per standard medical procedures, stenting procedure consists in the placement of stents above the main tumors of the right and left hepatic bile ducts via endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) when the ERCP approach has been unsuccessful. Other Names: Stents placement Drug: Chemotherapy regimen The regimen will comprise gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen may be administered if there is no disease progression or intolerable toxicity. Other Names: Gemcitabine/Cisplatin
Active Comparator: Standard Medical Care (SMC) Standard Medical Care (SMC) is defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen will comprise gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen may be administered if there is no disease progression or intolerable toxicity.	Procedure: Stenting procedure As per standard medical procedures, stenting procedure consists in the placement of stents above the main tumors of the right and left hepatic bile ducts via endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) when the ERCP approach has been unsuccessful. Other Names: Stents placement Drug: Chemotherapy regimen The regimen will comprise gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen may be administered if there is no disease progression or intolerable toxicity. Other Names: Gemcitabine/Cisplatin

Arm

Intervention/Treatment

Experimental: Photodynamic therapy-Photofrin plus SMC

Photodynamic therapy (PDT) involves the i.v. injection of Photofrin followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) will be applied to the tumor. A second light application will be given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients will undergo stenting as part of standard medical care procedure. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) may be given at 3-month intervals. Standard Medical Care (SMC) is defined as stenting procedure plus chemotherapy regimen.

Drug: Photodynamic therapy-Photofrin

Photodynamic therapy (PDT) involves the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device during an endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC). Two days after the injection, a laser light (180 J/cm(2)) will be applied to the tumor. A second light application will be given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients will undergo stenting as part of standard medical care procedure. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) may be given at 3-month intervals.

Other Names:

PDT-Photofrin

Procedure: Stenting procedure

As per standard medical procedures, stenting procedure consists in the placement of stents above the main tumors of the right and left hepatic bile ducts via endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) when the ERCP approach has been unsuccessful.

Other Names:

Stents placement

Drug: Chemotherapy regimen

The regimen will comprise gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen may be administered if there is no disease progression or intolerable toxicity.

Other Names:

Gemcitabine/Cisplatin

Active Comparator: Standard Medical Care (SMC)

Standard Medical Care (SMC) is defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen will comprise gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen may be administered if there is no disease progression or intolerable toxicity.

Procedure: Stenting procedure

Other Names:

Stents placement

Drug: Chemotherapy regimen

Other Names:

Gemcitabine/Cisplatin

Outcome Measures

Primary Outcome Measures

Overall Survival Time [Up to 26 months]
Time from the date of randomization until the date of death or the last date the subject was known to be alive

Secondary Outcome Measures

Time-to-bilirubin Response [Up to 30 days]
From the date of randomization until the date of first documented bilirubin response
Best Overall Tumor Response as Measured by the RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors) [Up to 26 months]
From the start of the treatment until disease progression or recurrence the RECIST 1.1 criteria are applied (Response Evaluation Criteria in Solid Tumors)
Time-to-tumor Progression [Up to 26 months]
From the date of first documented response until the date that tumor progression was assessed
Change From Baseline on Karnofsky Performance Scale (KPS) [Baseline, 7 days]
The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.
Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) [Baseline, up to 4 weeks]
The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death.
Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) [Baseline, 13 weeks]
The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death.
Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) [Baseline, 16 weeks]
The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death.
Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) [Baseline, 29 weeks]
The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.
Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) [Baseline, 41 weeks]
The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.
Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) [Baseline, 54 weeks]
The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.
Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) [Baseline, 66 weeks]
The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.
Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS) [Baseline, 78 weeks]
The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.
Change From Baseline in Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) [Baseline, 7 days]
Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.
Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30 [Baseline, up to 4 weeks]
Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.
Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30 [Baseline, 13 weeks]
Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.
Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30 [Baseline, 16 weeks]
Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.
Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30 [Baseline, 29 weeks]
Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.
Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30 [Baseline, 41 weeks]
Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.
Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30 [Baseline, 54 weeks]
Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.
Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30 [Baseline, 66 weeks]
Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.
Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30 [Baseline, 78 weeks]
Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males or females aged 18 or older
Diagnosed with radiologically and biopsy or cytology confirmed inoperable perihilar cholangiocarcinoma Bismuth Tumor Stage III/IV
Non-menopausal or non-sterile female subjects of childbearing potential must have a negative serum beta-HCG and use a medically acceptable form of birth control
Able to sign an informed consent

Exclusion Criteria:

Diagnostic of cholangiocarcinoma made more than 45 days prior to randomization
Cholangiocarcinoma with extra-hepatic metastasis or concurrent non-solid malignancy
Presence or history of other neoplasms (treated during the last five years prior to study entry) other than carcinoma in situ of the cervix or basal carcinoma of the skin
Previously received photodynamic therapy for cholangiocarcinoma
Previously undergone surgical resection of the cholangiocarcinoma
Previously undergone chemotherapy, brachytherapy, or radiotherapy prior to entering the study
Previously undergone metal stent insertion
Porphyria or hypersensitivity to porphyrins (constituents of porfimer sodium), gemcitabine, cisplatin or other platinum-containing compounds
Presence of infection other than the infection of the bile duct (cholangitis)
Acute or chronic medical or psychological illnesses that prevent endoscopy procedures
Abnormal blood test results
Severe impairment of your kidney or liver function
Decompensated cirrhosis
Pregnant or intend to become pregnant, breastfeeding or intend to breast-feed during this study
Participated in another drug study within 90 days before this one
Unable or unwilling to complete the follow-up evaluations required for the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Western Regional Medical Center, Inc.	Goodyear	Arizona	United States	85338
2	Mayo Clinic Cancer Center	Scottsdale	Arizona	United States	85259-5499
3	University of Southern California Keck School of Medicine	Los Angeles	California	United States	90033-1026
4	UC Davis Medical Center	Sacramento	California	United States	95817
5	University of Colorado Denver	Aurora	Colorado	United States	80045
6	Oschner Medical Center	Kenner	Louisiana	United States	70065
7	Henry Ford Health System	Detroit	Michigan	United States	48202
8	SUNY Downstate Medical Center	Brooklyn	New York	United States	11203
9	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
10	Weill Cornell Medical College	New York	New York	United States	10021
11	Columbia University Medical Center	New York	New York	United States	10032
12	Duke University Medical Center	Durham	North Carolina	United States	27710
13	Southwestern Regional Medical Center, Inc.	Tulsa	Oklahoma	United States	74133
14	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
15	Allegheny Center for Digestive Health - AHN ASRI	Pittsburgh	Pennsylvania	United States	15212
16	Methodist Dallas Medical Center	Dallas	Texas	United States	75208
17	Virginia Mason Medical Center	Seattle	Washington	United States	98101
18	Providence Sacred Heart Medical Center and Children's Hospital	Spokane	Washington	United States	99204
19	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
20	CHUM Hôpital St-Luc	Montreal	Quebec	Canada	H2X 3J4
21	Klinikum Ludwigsburg	Ludwigsburg	Baden Wuerttemberg	Germany	71640
22	Klinikum Mannheim GmbH	Mannheim	Baden Wuerttemberg	Germany	68167
23	Johann-Wolfgang-Goethe Universität Frankfurt	Frankfurt	Hessen	Germany	60590
24	Medizinische Hochschule Hannover	Hannover	Niedersachsen	Germany	30625
25	Universitätsklinikum Essen (AöR)	Essen	Nordrhein Westfalen	Germany	D-45147
26	Konkuk University Medical Center	Seoul	Gwangjin-gu	Korea, Republic of	143-729
27	Soonchunhyang University Bucheon Hospital	Bucheon City	Gyeonggi-do	Korea, Republic of	420-767
28	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	463-707
29	Severance Hospital, Yonsei University Health System	Seoul	Seodaemun-gu	Korea, Republic of	120-752
30	Seoul National University Hospital	Seoul		Korea, Republic of	110-744
31	UniversitätsSpital Zürich	Zürich		Switzerland	8091

Sponsors and Collaborators

Concordia Laboratories Inc.

Investigators

Principal Investigator: Michel Kahaleh, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Concordia Laboratories Inc.

ClinicalTrials.gov Identifier:

NCT02082522

Other Study ID Numbers:

PIN-PHO1201

First Posted:

Mar 10, 2014

Last Update Posted:

Aug 28, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Concordia Laboratories Inc.

Cholangiocarcinoma

Unresectable perihilar cholangiocarcinoma

Bile duct adenocarcinoma

Chemotherapy

Additional relevant MeSH terms:

Dihematoporphyrin Ether

Hematoporphyrin Derivative

Trioxsalen

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	An independent expert panel acted as central assessors for subjects across all sites. Central assessors prospectively interpreted all abdominal CT and cholangiogram images taken at screening to establish the final diagnosis and to confirm the randomization. Central assessors had the authority to overrule the investigator's diagnosis.

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Period Title: Overall Study
STARTED	15	13
COMPLETED	0	0
NOT COMPLETED	15	13

Baseline Characteristics

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)	Total
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.	Total of all reporting groups
Overall Participants	15	13	28
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.4 (11.84)	66.6 (7.69)	64.9 (10.08)
Sex: Female, Male (Count of Participants)
Female	3 20%	5 38.5%	8 28.6%
Male	12 80%	8 61.5%	20 71.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	12 80%	10 76.9%	22 78.6%
Unknown or Not Reported	3 20%	3 23.1%	6 21.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	5 33.3%	8 61.5%	13 46.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 6.7%	0 0%	1 3.6%
White	9 60%	4 30.8%	13 46.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 7.7%	1 3.6%
Region of Enrollment (participants) [Number]
South Korea	5 33.3%	8 61.5%	13 46.4%
United States	9 60%	4 30.8%	13 46.4%
Germany	1 6.7%	1 7.7%	2 7.1%

Outcome Measures

1. Primary Outcome

Title	Overall Survival Time
Description	Time from the date of randomization until the date of death or the last date the subject was known to be alive
Time Frame	Up to 26 months

Outcome Measure Data

Analysis Population Description
All participants randomized (intent-to-treat population)

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	15	13
Median (95% Confidence Interval) [days]	444	387

2. Secondary Outcome

Title	Time-to-bilirubin Response
Description	From the date of randomization until the date of first documented bilirubin response
Time Frame	Up to 30 days

Outcome Measure Data

Analysis Population Description
Data not collected

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	0	0

3. Secondary Outcome

Title	Best Overall Tumor Response as Measured by the RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors)
Description	From the start of the treatment until disease progression or recurrence the RECIST 1.1 criteria are applied (Response Evaluation Criteria in Solid Tumors)
Time Frame	Up to 26 months

Outcome Measure Data

Analysis Population Description
Due to the premature termination of the study, there was insufficient data to allow statistical analysis.

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	9	8
Number [percentage of participants]	56 373.3%	75 576.9%

4. Secondary Outcome

Title	Time-to-tumor Progression
Description	From the date of first documented response until the date that tumor progression was assessed
Time Frame	Up to 26 months

Outcome Measure Data

Analysis Population Description
Not collected

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	0	0

5. Secondary Outcome

Title	Change From Baseline on Karnofsky Performance Scale (KPS)
Description	The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.
Time Frame	Baseline, 7 days

Outcome Measure Data

Analysis Population Description
At Day 7, all 15 subjects in the PDT +SMC group were analysed and 9/13 in the SMC Alone group were analysed.

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	15	9
Mean (Standard Deviation) [score on a scale]	-0.7 (7.99)	0 (0)

6. Secondary Outcome

Title	Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
Description	The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death.
Time Frame	Baseline, up to 4 weeks

Outcome Measure Data

Analysis Population Description
At 4 weeks, 12 subjects in the PDT +SMC group were analysed and 9 in the SMC Alone group were analysed.

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	12	9
Mean (Standard Deviation) [score on a scale]	1.7 (5.77)	0 (0)

7. Secondary Outcome

Title	Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
Description	The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death.
Time Frame	Baseline, 13 weeks

Outcome Measure Data

Analysis Population Description
At 13 weeks, 8 subjects in the PDT +SMC group were analysed and 8 in the SMC Alone group were analysed. Due to the premature termination of the study, there was insufficient data to allow statistical analysis.

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	8	8
Mean (Standard Deviation) [score on a scale]	0.0 (7.56)	2.5 (4.63)

8. Secondary Outcome

Title	Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
Description	The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description
At 16 weeks, 9 subjects in the PDT +SMC group were analysed and 9 in the SMC Alone group were analysed. Due to the premature termination of the study, there was insufficient data to allow statistical analysis.

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	9	9
Mean (Standard Deviation) [score on a scale]	-6.7 (15.00)	3.3 (5.00)

9. Secondary Outcome

Title	Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
Description	The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.
Time Frame	Baseline, 29 weeks

Outcome Measure Data

Analysis Population Description
At 29 weeks, 6 subjects in the PDT +SMC group were analysed and 5 in the SMC Alone group were analysed. Due to the premature termination of the study, there was insufficient data to allow statistical analysis.

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	6	5
Mean (Standard Deviation) [score on a scale]	0.0 (8.94)	2.0 (4.47)

10. Secondary Outcome

Title	Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
Description	The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.
Time Frame	Baseline, 41 weeks

Outcome Measure Data

Analysis Population Description
At 41 weeks, 2 subjects in the PDT +SMC group were analysed and 1 in the SMC Alone group was analysed. Due to the premature termination of the study, there was insufficient data to allow statistical analysis.

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	2	1
Mean (Standard Deviation) [score on a scale]	10.0 (14.14)	0.0 (0.0)

11. Secondary Outcome

Title	Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
Description	The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.
Time Frame	Baseline, 54 weeks

Outcome Measure Data

Analysis Population Description
At 54 weeks, only 1 subject in each group was measured. Due to the premature termination of the study, there was insufficient data to allow statistical analysis.

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	1	1
Mean (Standard Deviation) [score on a scale]	0.0 (0.0)	0.0 (0.0)

12. Secondary Outcome

Title	Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
Description	The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.
Time Frame	Baseline, 66 weeks

Outcome Measure Data

Analysis Population Description
Data not collected

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	0	0

13. Secondary Outcome

Title	Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)
Description	The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.
Time Frame	Baseline, 78 weeks

Outcome Measure Data

Analysis Population Description
Not collected

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	0	0

14. Secondary Outcome

Title	Change From Baseline in Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
Description	Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.
Time Frame	Baseline, 7 days

Outcome Measure Data

Analysis Population Description
Due to the premature termination of the study, there was insufficient data to allow statistical analysis.

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	15	9
Mean (Standard Deviation) [score on a scale]	-2.2 (30.29)	0.0 (0.0)

15. Secondary Outcome

Title	Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
Description	Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.
Time Frame	Baseline, up to 4 weeks

Outcome Measure Data

Analysis Population Description
Not collected

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	0	0

16. Secondary Outcome

Title	Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
Description	Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.
Time Frame	Baseline, 13 weeks

Outcome Measure Data

Analysis Population Description
Due to the premature termination of the study, there was insufficient data to allow statistical analysis.

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	7	8
Mean (Standard Deviation) [score on a scale]	-7.1 (30.59)	6.2 (35.84)

17. Secondary Outcome

Title	Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
Description	Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description
Due to the premature termination of the study, there was insufficient data to allow statistical analysis.

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	9	8
Mean (Standard Error) [score on a scale]	-21.3 (33.88)	10.4 (31.10)

18. Secondary Outcome

Title	Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
Description	Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.
Time Frame	Baseline, 29 weeks

Outcome Measure Data

Analysis Population Description
Due to the premature termination of the study, there was insufficient data to allow statistical analysis.

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	4	5
Mean (Standard Deviation) [score on a scale]	-12.5 (35.03)	5.0 (18.26)

19. Secondary Outcome

Title	Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
Description	Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.
Time Frame	Baseline, 41 weeks

Outcome Measure Data

Analysis Population Description
Due to the premature termination of the study, there was insufficient data to allow statistical analysis.

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	2	2
Mean (Standard Deviation) [score on a scale]	8.3 (11.79)	-16.7 (23.57)

20. Secondary Outcome

Title	Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
Description	Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.
Time Frame	Baseline, 54 weeks

Outcome Measure Data

Analysis Population Description
Due to the premature termination of the study, there was insufficient data to allow statistical analysis.

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	1	1
Mean (Standard Deviation) [score on a scale]	-8.3 (NA)	-33.3 (NA)

21. Secondary Outcome

Title	Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
Description	Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.
Time Frame	Baseline, 66 weeks

Outcome Measure Data

Analysis Population Description
No data collected

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	0	0

22. Secondary Outcome

Title	Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30
Description	Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.
Time Frame	Baseline, 78 weeks

Outcome Measure Data

Analysis Population Description
No data collected

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC	Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.	Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
Measure Participants	0	0

Adverse Events

	Photodynamic Therapy-Photofrin Plus SMC		Standard Medical Care (SMC)
Time Frame	26 months
Adverse Event Reporting Description	The SMC alone group enrolled 13 subjects but only 10 were treated thus there were only 10 subjects at risk for adverse events.

Arm/Group Title	Photodynamic Therapy-Photofrin Plus SMC		Standard Medical Care (SMC)
Arm/Group Description	Photodynamic therapy (PDT) involved the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device. Two days after the injection, a laser light (180 J/cm(2)) was applied to the tumor. A second light application was given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients underwent stenting. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) could be given at 3-month intervals. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity.		Standard Medical Care (SMC) was defined as stenting procedure plus chemotherapy regimen. The chemotherapy regimen comprised gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen could be administered if there was no disease progression or intolerable toxicity. As per SMC, stenting procedure consisted of the placement of stents above the main tumors of the right and left hepatic bile ducts.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/15 (6.7%)		0/13 (0%)
Serious Adverse Events
	Photodynamic Therapy-Photofrin Plus SMC		Standard Medical Care (SMC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/15 (73.3%)		10/10 (100%)
Blood and lymphatic system disorders
Anemia	0/15 (0%)	0	1/10 (10%)	1
Pancytopenia	2/15 (13.3%)	2	1/10 (10%)	1
Thrombocytopenia	0/15 (0%)	0	2/10 (20%)	2
Gastrointestinal disorders
Abdominal pain	1/15 (6.7%)	1	0/10 (0%)	0
Ascites	1/15 (6.7%)	1	0/10 (0%)	0
General disorders
Catheter site pain	0/15 (0%)	0	1/10 (10%)	1
Pyrexia	2/15 (13.3%)	2	0/10 (0%)	0
Hepatobiliary disorders
Biloma	0/15 (0%)	0	1/10 (10%)	1
Cholangitis	6/15 (40%)	6	9/10 (90%)	9
Cholecystitis	0/15 (0%)	0	1/10 (10%)	1
Haemobilia	1/15 (6.7%)	1	0/10 (0%)	0
Hepatitis cholestatic	1/15 (6.7%)	1	0/10 (0%)	0
Jaundice	1/15 (6.7%)	1	1/10 (10%)	1
Portal vein thrombosis	1/15 (6.7%)	1	0/10 (0%)	0
Cholangitis acute	1/15 (6.7%)	1	1/10 (10%)	1
Infections and infestations
Sepsis	5/15 (33.3%)	8	3/10 (30%)	4
Septic shock	3/15 (20%)	3	0/10 (0%)	0
Liver abcess	1/15 (6.7%)	1	1/10 (10%)	1
Injury, poisoning and procedural complications
Post-procedural complications	1/15 (6.7%)	1	0/10 (0%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain	0/15 (0%)	0	1/10 (10%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/15 (6.7%)	1	0/10 (0%)	0
Vascular disorders
Deep vein thrombosis	1/15 (6.7%)	1	0/10 (0%)	0
Embolism	1/15 (6.7%)	1	0/10 (0%)	0
Other (Not Including Serious) Adverse Events
	Photodynamic Therapy-Photofrin Plus SMC		Standard Medical Care (SMC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/15 (86.7%)		10/10 (100%)
Blood and lymphatic system disorders
Iron deficiency anemia	3/15 (20%)	3	2/10 (20%)	2
Pancytopenia	1/15 (6.7%)	1	0/10 (0%)	0
Neutropenia	2/15 (13.3%)	2	3/10 (30%)	3
Thrombocytopenia	1/15 (6.7%)	1	2/10 (20%)	2
Anemia	1/15 (6.7%)	1	1/10 (10%)	1
Aplastic anemia	0/15 (0%)	0	1/10 (10%)	1
Lymphadenitis	1/15 (6.7%)	1	0/10 (0%)	0
Splenic infarction	1/15 (6.7%)	1	0/10 (0%)	0
Splenomegaly	1/15 (6.7%)	1	0/10 (0%)	0
Cardiac disorders
Cardiac failure congestive	1/15 (6.7%)	1	0/10 (0%)	0
Tachycardia	0/15 (0%)	0	1/10 (10%)	1
Ear and labyrinth disorders
Eustachian tube dysfunction	0/15 (0%)	0	1/10 (10%)	1
Endocrine disorders
Adrenal insufficiency	1/15 (6.7%)	1	0/10 (0%)	0
Eye disorders
Vision blurred	2/15 (13.3%)	2	0/10 (0%)	0
Cataract	0/15 (0%)	0	1/10 (10%)	1
Conjuctival hemorrhage	0/15 (0%)	0	1/10 (10%)	1
Diplopia	1/15 (6.7%)	1	0/10 (0%)	0
Eye swelling	1/15 (6.7%)	1	0/10 (0%)	0
Gastrointestinal disorders
Nausea	9/15 (60%)	9	2/10 (20%)	2
Abdominal pain	7/15 (46.7%)	7	5/10 (50%)	5
Constipation	7/15 (46.7%)	7	3/10 (30%)	3
Ascites	3/15 (20%)	3	1/10 (10%)	1
Dry mouth	2/15 (13.3%)	2	0/10 (0%)	0
Dyspepsia	2/15 (13.3%)	2	1/10 (10%)	1
Vomiting	2/15 (13.3%)	2	3/10 (30%)	3
Abdominal pain upper	4/15 (26.7%)	4	1/10 (10%)	1
Abdominal discomfort	0/15 (0%)	0	1/10 (10%)	1
Abdominal distension	0/15 (0%)	0	1/10 (10%)	1
Diarrhea	1/15 (6.7%)	1	0/10 (0%)	0
Duodenal stenosis	0/15 (0%)	0	1/10 (10%)	1
Dysphagia	1/15 (6.7%)	1	0/10 (0%)	0
Feces discolored	1/15 (6.7%)	1	0/10 (0%)	0
Gastric ulcer	1/15 (6.7%)	1	0/10 (0%)	0
GERD	1/15 (6.7%)	1	0/10 (0%)	0
Hiatus hernia	1/15 (6.7%)	1	0/10 (0%)	0
Ileus	0/15 (0%)	0	1/10 (10%)	1
Small intestinal hemorrhage	1/15 (6.7%)	1	0/10 (0%)	0
Stomatitis	1/15 (6.7%)	1	1/10 (10%)	1
General disorders
Fatigue	6/15 (40%)	6	2/10 (20%)	4
Pyrexia	3/15 (20%)	3	6/10 (60%)	6
Chills	4/15 (26.7%)	4	4/10 (40%)	4
Asthenia	3/15 (20%)	3	2/10 (20%)	2
Catheter site pain	2/15 (13.3%)	2	1/10 (10%)	1
Edema peripheral	2/15 (13.3%)	2	0/10 (0%)	0
Catheter site discharge	1/15 (6.7%)	1	1/10 (10%)	1
Catheter site injury	0/15 (0%)	0	1/10 (10%)	1
Generalized edema	0/15 (0%)	0	1/10 (10%)	1
Influenza-like illness	0/15 (0%)	0	1/10 (10%)	1
Non-cardiac chest pain	1/15 (6.7%)	1	0/10 (0%)	0
Peripheral swelling	1/15 (6.7%)	1	1/10 (10%)	1
Hepatobiliary disorders
Cholangitis	1/15 (6.7%)	1	0/10 (0%)	0
Cholangitis acute	0/15 (0%)	0	1/10 (10%)	1
Bile duct obstruction	1/15 (6.7%)	1	0/10 (0%)	0
Cholecystitis	0/15 (0%)	0	1/10 (10%)	1
Cholestasis	0/15 (0%)	0	1/10 (10%)	1
Gallbladder perforation	0/15 (0%)	0	1/10 (10%)	1
Jaundice	1/15 (6.7%)	1	0/10 (0%)	0
Portal hypertension	1/15 (6.7%)	1	0/10 (0%)	0
Infections and infestations
Septic shock	1/15 (6.7%)	1	0/10 (0%)	0
Sepsis	1/15 (6.7%)	1	1/10 (10%)	1
Biliary tract infection bacteria	0/15 (0%)	0	1/10 (10%)	1
Candida infection	1/15 (6.7%)	1	0/10 (0%)	0
Catheter site infection	0/15 (0%)	0	1/10 (10%)	1
Enterococcal bacteremia	1/15 (6.7%)	1	1/10 (10%)	1
Herpes simplex	0/15 (0%)	0	1/10 (10%)	1
Oral candidiasis	0/15 (0%)	0	1/10 (10%)	1
Tinea pedis	1/15 (6.7%)	1	0/10 (0%)	0
Upper respiratory tract infection	1/15 (6.7%)	1	1/10 (10%)	1
Urinary tract infection	1/15 (6.7%)	1	0/10 (0%)	0
Injury, poisoning and procedural complications
Nausea	1/15 (6.7%)	2	0/10 (0%)	0
Skin cut	1/15 (6.7%)	1	0/10 (0%)	0
Procedural nausea	1/15 (6.7%)	1	0/10 (0%)	0
Procedural vomiting	1/15 (6.7%)	1	0/10 (0%)	0
Skin wound	1/15 (6.7%)	1	0/10 (0%)	0
Investigations
Bilirubine increase	3/15 (20%)	3	0/10 (0%)	0
CA-19 increase	2/15 (13.3%)	2	0/10 (0%)	0
GGT	2/15 (13.3%)	2	0/10 (0%)	0
Weight decreased	2/15 (13.3%)	2	0/10 (0%)	0
AST increased	1/15 (6.7%)	1	0/10 (0%)	0
Alkaline phosphatase increased	1/15 (6.7%)	1	0/10 (0%)	0
Blood creatinine increased	0/15 (0%)	0	1/10 (10%)	1
Blood magnesium decreased	1/15 (6.7%)	1	0/10 (0%)	0
Blood potassium decreased	1/15 (6.7%)	1	0/10 (0%)	0
Blood urea increased	1/15 (6.7%)	1	0/10 (0%)	0
Hemoglobin decreased	1/15 (6.7%)	1	0/10 (0%)	0
Heart rate increased	1/15 (6.7%)	1	0/10 (0%)	0
INR increased	1/15 (6.7%)	1	0/10 (0%)	0
Neutrophil count decreased	0/15 (0%)	0	1/10 (10%)	1
Platelet count decreased	1/15 (6.7%)	1	1/10 (10%)	1
Pulse abnormal	1/15 (6.7%)	1	0/10 (0%)	0
Metabolism and nutrition disorders
Decreased appetite	6/15 (40%)	6	2/10 (20%)	2
Hypokaliemia	2/15 (13.3%)	2	3/10 (30%)	3
Hypoalbuminemia	1/15 (6.7%)	1	3/10 (30%)	3
Fluid imbalance	0/15 (0%)	0	1/10 (10%)	1
Fluid overload	0/15 (0%)	0	1/10 (10%)	1
Hyperglycemia	0/15 (0%)	0	1/10 (10%)	1
Hyperkaliemia	0/15 (0%)	0	1/10 (10%)	1
Hypocalcemia	1/15 (6.7%)	1	1/10 (10%)	1
Hypomagnesemia	1/15 (6.7%)	1	0/10 (0%)	0
Hyponatremia	1/15 (6.7%)	1	1/10 (10%)	1
Vitamine D deficiency	1/15 (6.7%)	1	0/10 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	2/15 (13.3%)	2	0/10 (0%)	0
Pain in extremity	0/15 (0%)	0	2/10 (20%)	2
Groin pain	1/15 (6.7%)	1	0/10 (0%)	0
Joint stiffness	1/15 (6.7%)	1	0/10 (0%)	0
Muscle tightness	1/15 (6.7%)	1	0/10 (0%)	0
Nervous system disorders
Headache	4/15 (26.7%)	4	3/10 (30%)	3
Dizziness	3/15 (20%)	3	0/10 (0%)	0
Neuropathy peripheral	2/15 (13.3%)	2	0/10 (0%)	0
Asterixis	1/15 (6.7%)	1	0/10 (0%)	0
Dysgeusia	1/15 (6.7%)	1	0/10 (0%)	0
Hyperaesthesia	1/15 (6.7%)	1	0/10 (0%)	0
Psychiatric disorders
Insomnia	3/15 (20%)	3	2/10 (20%)	2
Anxiety	3/15 (20%)	3	0/10 (0%)	0
Abnormal dreams	1/15 (6.7%)	1	0/10 (0%)	0
Agitation	1/15 (6.7%)	1	0/10 (0%)	0
Depression	1/15 (6.7%)	1	0/10 (0%)	0
Food aversion	1/15 (6.7%)	1	0/10 (0%)	0
Renal and urinary disorders
Chromaturia	1/15 (6.7%)	1	0/10 (0%)	0
Uretherolithiasis	0/15 (0%)	0	1/10 (10%)	1
Calculus bladder	1/15 (6.7%)	1	0/10 (0%)	0
Pollakiuria	1/15 (6.7%)	2	0/10 (0%)	0
Urethrolithiasis	0/15 (0%)	0	1/10 (10%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea	3/15 (20%)	3	2/10 (20%)	2
Oropharyngeal pain	2/15 (13.3%)	2	1/10 (10%)	1
Atelectasis	2/15 (13.3%)	2	0/10 (0%)	0
Epistaxis	2/15 (13.3%)	2	0/10 (0%)	0
Productive cough	0/15 (0%)	0	2/10 (20%)	2
Cough	1/15 (6.7%)	1	1/10 (10%)	1
Hiccups	1/15 (6.7%)	1	1/10 (10%)	1
Pulmonary congestion	0/15 (0%)	0	1/10 (10%)	1
Pulmonary embolism	0/15 (0%)	0	1/10 (10%)	1
Rhinorrhea	1/15 (6.7%)	1	0/10 (0%)	0
Tonsillar disorder	0/15 (0%)	0	1/10 (10%)	1
Upper airway cough syndrome	1/15 (6.7%)	1	0/10 (0%)	0
Skin and subcutaneous tissue disorders
Rash	5/15 (33.3%)	5	0/10 (0%)	0
Pruritis	3/15 (20%)	3	1/10 (10%)	1
Night sweats	2/15 (13.3%)	2	0/10 (0%)	0
Alopecia	0/15 (0%)	0	1/10 (10%)	1
Blister	1/15 (6.7%)	1	0/10 (0%)	0
Palmar-plantar erythrodysaesthesia	1/15 (6.7%)	1	1/10 (10%)	1
Photosensitivity reaction	1/15 (6.7%)	1	0/10 (0%)	0
Pruritis generalized	1/15 (6.7%)	1	0/10 (0%)	0
Rash erythmetous	1/15 (6.7%)	1	0/10 (0%)	0
Solar lentigo	1/15 (6.7%)	1	0/10 (0%)	0
Swelling face	1/15 (6.7%)	1	0/10 (0%)	0
Vascular disorders
Hypotension	1/15 (6.7%)	1	3/10 (30%)	3
Deep vein thrombosis	0/15 (0%)	0	2/10 (20%)	2

Limitations/Caveats

This study was prematurely terminated due to low accrual. Consequently, there was insufficient data to allow statistical analysis. Only descriptive statistics are presented for the primary endpoint, overall survival time.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title	Dr. Michelle Depot
Organization	At the request of Concordia Laboratories Inc.
Phone
Email	michelle.depot@advanzpharma.com

Responsible Party:

Concordia Laboratories Inc.

ClinicalTrials.gov Identifier:

NCT02082522

Other Study ID Numbers:

PIN-PHO1201

First Posted:

Mar 10, 2014

Last Update Posted:

Aug 28, 2019

Last Verified:

Aug 1, 2019

Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)

Study Details

Study Description

Brief Summary

Detailed Description

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact