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

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..

Study Overview

• Status: Recruiting
• Conditions: Intrahepatic Cholangiocarcinoma
• Intervention / Treatment: Procedure: Liver Transplant

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magnus Smedman, MD; Phone Number: +47 23026600; Email: torha@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0451
    • Recruiting
    • Oslo University Hospital
    • Contact: Magnus Smedman, MD; Phone Number: 47 23026600; Email: torha@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS as assessed by quality of life questionnaire (QLQ-C30) patient reported outcome	From screening and until 36 months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival	CT-scan/MRI scan according to RECISTcriteria	After liver transplantation and up 10 years after liver transplantation
Overall Survival from time of relapse	OS as assessed by QLQ-C30 patient reported outcome	From time of relapse and until 36 months after inclusion
Start of new treatment/Change of strategy	Time to start of new treatment	Immediately after liver transplatation to start of new treatment
Time to decrease in physical function and global health score	Quality of life measured by EORTC QLQ-C30),	Up to 10 years after liver transplantation
Liver transplant Complication	Number of Clavien-Dindo grad 3-5 complications	Up to 90 days after liver transplantation
Number of Participants Developing other Malignancies	Diagnosis of other malignancies	Up to 10 years after liver transplantation
Survival in relation to biological markers	CEA, CA 19-9 and Germline DNA analyses	After Liver Transplant until 10 years after liver transplantation

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Magnus Smedman, MD, Oslo University Hospital; Principal Investigator: Sheraz Yaqub, MD, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): May 31, 2035
• Study Completion (Anticipated): May 31, 2035

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma
• Other Study ID Numbers: TESLA trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No