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

NCT04556214 | Recruiting DMC

• 1 other identifier: TESLA trial
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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..

Conditions

Intrahepatic Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Overall Survival from time of relapse

  From time of relapse and until 36 months after inclusion

• Disease free survival

  After liver transplantation and up 10 years after liver transplantation

• Start of new treatment/Change of strategy

  Immediately after liver transplatation to start of new treatment

• Time to decrease in physical function and global health score

  Up to 10 years after liver transplantation

• Liver transplant Complication

  Up to 90 days after liver transplantation

Study Arms (1)

Liver Transplant

EXPERIMENTAL

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

Interventions

Liver Transplant PROCEDURE

Liver Transplant

Liver Transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0451, Norway

RECRUITING

Related Publications (1)

• Achurra P, Fernandes E, O'Kane G, Grant R, Cattral M, Sapisochin G. Liver transplantation for intrahepatic cholangiocarcinoma: who, when and how. Curr Opin Organ Transplant. 2024 Apr 1;29(2):161-171. doi: 10.1097/MOT.0000000000001136. Epub 2024 Jan 23.

  PMID: 38258823 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Magnus Smedman, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Sheraz Yaqub, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magnus Smedman, MD

CONTACT

23026600; torha@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, gastrointestinal oncology

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: September 21, 2020
• Study Start: June 1, 2020
• Primary Completion (Estimated): May 31, 2035
• Study Completion (Estimated): May 31, 2035
• Last Updated: April 11, 2023

Record last verified: 2023-04

Locations

NO (1)