Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04556214
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 179.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The study will investigate whether liver transplantation provides increased survival, low side effects and good quality of life in patients with bile duct cancer where the tumor cannot be removed by normal surgery. Analyzes of blood and tissue samples from the tumor will be investigated to see if the analyzes can indicate who may have recurrence of the disease after liver transplantation. Furthermore, the effect of chemotherapy on normal liver and tumor tissues in the liver that are removed during transplantation will be investigated..

Condition or Disease	Intervention/Treatment	Phase
Intrahepatic Cholangiocarcinoma	Procedure: Liver Transplant	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)
• Actual Study Start Date: Jun 1, 2020
• Anticipated Primary Completion Date: May 31, 2035
• Anticipated Study Completion Date: May 31, 2035

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Liver Transplant The patients will be transplanted according to standard procedures by the institutional protocol. The transplantation procedure is initiated by an exploratory laparotomy with clinical assessment and frozen section of the lymphnodes in the hepatoduodenal ligament and along the common hepatic artery/coeliac axis. Evidence of disease dissemination to these regional lymph nodes will be an absolute contraindication to transplantation.

Procedure: Liver Transplant; Liver Transplant

Outcome Measures

Primary Outcome Measures

1. Overall Survival (OS) [From screening and until 36 months after inclusion]

   OS as assessed by quality of life questionnaire (QLQ-C30) patient reported outcome

Secondary Outcome Measures

1. Overall Survival from time of relapse [From time of relapse and until 36 months after inclusion]

   OS as assessed by QLQ-C30 patient reported outcome

2. Disease free survival [After liver transplantation and up 10 years after liver transplantation]

   CT-scan/MRI scan according to RECISTcriteria

3. Start of new treatment/Change of strategy [Immediately after liver transplatation to start of new treatment]

   Time to start of new treatment

4. Time to decrease in physical function and global health score [Up to 10 years after liver transplantation]

   Quality of life measured by EORTC QLQ-C30),

5. Liver transplant Complication [Up to 90 days after liver transplantation]

   Number of Clavien-Dindo grad 3-5 complications

6. Number of Participants Developing other Malignancies [Up to 10 years after liver transplantation]

   Diagnosis of other malignancies

7. Survival in relation to biological markers [After Liver Transplant until 10 years after liver transplantation]

   CEA, CA 19-9 and Germline DNA analyses

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Histologically verified diagnosis of Intrahepatic Cholangiocarcinoma (iCCA)

• First time iCCA or liver only recurrence after previous liver resection for iCCA

• Disease deemed not eligible for liver resection based on tumor location or underlying liver dysfunction

• No vascular invasion, extrahepatic disease, or lymph node involvement detected on imaging

• No signs of extrahepatic metastatic disease according to positron emission computed tomography (PET-CT) scan

• Patient must be accepted for transplantation before progressive disease on chemotherapy.

• Twelve months or more time span from the diagnosis of iCCA and date of being listed for liver transplantation

• No signs of extrahepatic metastatic disease according to CT or magnetic resonance (MR) scan within 4 weeks prior to the faculty meeting at the transplant unit

• At least 18 years of age

• Good performance status, Eastern Cooperative Oncology Group (ECOG) 0 or 1

• Signed informed consent and expected cooperation of the patients for the treatment and follow up

• Received at least 6 months of chemotherapy or locoregional therapy

Exclusion Criteria:

• Major vascular involvement of the tumor

• Perforation of the visceral peritoneum

• Weight loss >15% the last 6 months

• Patient BMI > 30

• Other malignancies, except curatively treated more than 5 years ago without relapse

• Known history of human immunodeficiency virus (HIV) infection

• Prior history of solid organ or bone marrow transplantation

• Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results

• Known hypersensitivity to rapamycin

• Prior extrahepatic metastatic disease

• Women who are pregnant or breast feeding

• Any reason why, in the opinion of the investigator, the patient should not participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway	0310

Sponsors and Collaborators

• Oslo University Hospital

Investigators

• Principal Investigator: Svein Dueland, PhDMD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Svein Dueland, Senior consultant medical oncology, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT04556214
• Other Study ID Numbers: TESLA trial
• First Posted: Sep 21, 2020
• Last Update Posted: Oct 19, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cholangiocarcinoma

Study Results

No Results Posted as of Oct 19, 2020