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

NCT ID: NCT04556214

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2035-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Liver Transplant

Intervention Type: PROCEDURE

Liver Transplant

Interventions

Liver Transplant

Liver Transplant

Intervention Type: PROCEDURE

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Magnus Smedman, MD

Consultant, gastrointestinal oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magnus Smedman, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Sheraz Yaqub, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Magnus Smedman, MD

Role: CONTACT

torha@ous-hf.no

23026600 ext. +47

Facility Contacts

Magnus Smedman, MD

Role: primary

torha@ous-hf.no

23026600 ext. 47

References

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.

Reference Type: DERIVED

PMID: 38258823 (View on PubMed)

Other Identifiers

TESLA trial

Identifier Type: -

Identifier Source: org_study_id