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

Oslo University Hospital1 site in 1 country15 target enrollmentJune 1, 2020

ConditionsIntrahepatic Cholangiocarcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intrahepatic Cholangiocarcinoma
Sponsor: Oslo University Hospital
Enrollment: 15
Locations: 1
Primary Endpoint: Overall Survival (OS)
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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..

Registry

clinicaltrials.gov

Start Date

June 1, 2020

End Date

May 31, 2035

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Oslo University Hospital

Responsible Party

Principal Investigator

Magnus Smedman, MD

Consultant, gastrointestinal oncology

Oslo University Hospital

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Overall Survival (OS)

Time Frame: From screening and until 36 months after inclusion

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

Secondary Outcomes

Disease free survival(After liver transplantation and up 10 years after liver transplantation)
Time to decrease in physical function and global health score(Up to 10 years after liver transplantation)
Overall Survival from time of relapse(From time of relapse and until 36 months after inclusion)
Number of Participants Developing other Malignancies(Up to 10 years after liver transplantation)
Start of new treatment/Change of strategy(Immediately after liver transplatation to start of new treatment)
Liver transplant Complication(Up to 90 days after liver transplantation)
Survival in relation to biological markers(After Liver Transplant until 10 years after liver transplantation)