Toripalimab Combined With S1 and Albumin Paclitaxel in Patients With Advanced Biliary Tract Cancer

• Sponsor: Dai, Guanghai (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04027764
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The investigator's study is a single armed phrase II trial ,aiming to improve the effecacy of treatment for advanced billiary tract cancer by means of Toripalimab combining with S1 and Albumin Paclitaxel as first line in patients with advanced Biliary Tract Cancer. treatment continually until disease progression or intolerable toxicity or Patients withdrawal of consent.and target sample is 30+ patients.

Condition or Disease	Intervention/Treatment	Phase
Advanced Biliary Tract Cancer	Drug: Toripalimab Combined With S1 and Albumin Paclitaxel	Phase 2

Detailed Description

Toripalimab: 240 mg , once every 2-3 weeks; S1: 80-120mg, bid; oral, day1-14; Albumin paclitaxel: 120mg/m2 , administered on the first day and the eighth day of each cycle; 21 days for a treatment cycle

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Toripalimab Combined With S1 and Albumin Paclitaxel as First Line in Patients With Advanced Biliary Tract Cancer: a Single-arm,One Center， Phase II Clinical Study
• Actual Study Start Date: May 1, 2019
• Anticipated Primary Completion Date: May 1, 2020
• Anticipated Study Completion Date: May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Toripalimab Combined With S1 and Albumin Paclitaxel	Drug: Toripalimab Combined With S1 and Albumin Paclitaxel; Toripalimab 240 mg ，every 2-3 weeks S1：80-120mg，bid；oral，d1-14； Albumin Paclitaxel：120mg/m2，D 1 \8; Other Names: TSA

Outcome Measures

Primary Outcome Measures

1. objective response rate [1 year]

   ORR

Secondary Outcome Measures

1. progression free survival [1 year]

   PFS

2. disease response rate [1 year]

   DCR

3. overall survival [1 year]

   OS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age ≥ 18 years old

2. Patients with gallbladder and cholangiocarcinoma diagnosed by histology or cytology

3. Liver function Child-Pugh grade A (5-6 points) or better grade B (≤ 7 points)

4. ECOG score 0 or 1 point

5. At least one measurable lesion

6. no previous treatment

Exclusion Criteria:

1. organs failure ,including liver ,heart ,kidney

2. Have received a liver transplant in the past

3. Active brain metastasis or spinal cord compression

4. ECOG score 3 or 4 point

5. Symptomatic peripheral neuropathy (CTCAE ≥ 2)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chinese PLA General Hospital	Beijing	Beijing	China	100853

Sponsors and Collaborators

• Dai, Guanghai

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dai, Guanghai, professor,deputy cheif of oncology department, Chinese PLA General Hospital
• ClinicalTrials.gov Identifier: NCT04027764
• Other Study ID Numbers: TSA-01
• First Posted: Jul 22, 2019
• Last Update Posted: Jul 22, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dai, Guanghai, professor,deputy cheif of oncology department, Chinese PLA General Hospital: advanced biliary tract cancer; Albumin Paclitaxel; s1; Toripalimab
• Additional relevant MeSH terms: Biliary Tract Neoplasms; Paclitaxel

Study Results

No Results Posted as of Jul 22, 2019