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

Not Applicable

Recruiting

• Conditions: Intrahepatic Cholangiocarcinoma

• Registration Number: NCT04556214
• Lead Sponsor: Oslo University Hospital

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..

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11
• Primary Completion: 2035-05-31
• Study Completion: 2035-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Disease free survival	After liver transplantation and up 10 years after liver transplantation	CT-scan/MRI scan according to RECISTcriteria
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),
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
Number of Participants Developing other Malignancies	Up to 10 years after liver transplantation	Diagnosis of other malignancies
Start of new treatment/Change of strategy	Immediately after liver transplatation to start of new treatment	Time to start of new treatment
Liver transplant Complication	Up to 90 days after liver transplantation	Number of Clavien-Dindo grad 3-5 complications
Survival in relation to biological markers	After Liver Transplant until 10 years after liver transplantation	CEA, CA 19-9 and Germline DNA analyses

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway