Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma

Launched by FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI, MILANO · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the possibility of using liver transplantation for patients who have a type of cancer called unresectable perihilar cholangiocarcinoma, also known as a Klatskin tumor. In this study, researchers want to see if patients can have successful treatment to shrink or control their cancer with chemotherapy, immunotherapy, and a type of radiation therapy called stereotactic body radiation therapy (SBRT) before they undergo a liver transplant. The goal is to find out if this approach can help more patients become eligible for transplantation and improve their outcomes.

To participate in this trial, individuals need to be between 18 and 70 years old and have a specific type of bile duct cancer that is not able to be surgically removed. They should not have any spread of cancer to other parts of the body, and they need to meet certain health criteria, like having no other active cancers in the past five years. Participants can expect to be part of a multi-center study, meaning they will be contributing to research across several locations, and they will need to provide written consent to join. This study is currently recruiting participants, so there are opportunities for eligible patients to get involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Diagnosis of unresectable peripheral cholangiocarcinoma arising one centimeter or more above the superior pancreatic margin, with tumor diameter ≤ 3 cm, diagnosed by:
• • Transcatheter biopsy or brush cytology
• • CA-19.9 \> 100 mg/ml and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography
• • Biliary ploidy by FISH with a malignant appearing stricture on cholangiography
• • Age between 18 years and 70 years
• • Absence of intra- and extrahepatic metastases
• • Absence of lymph-nodal metastases at any site
• • Biliary stenting of all liver districts
• • No contraindications to liver transplantation
• • No concomitant malignancies or history of other malignancies in the previous 5 years
• • Written informed consent
• Exclusion Criteria:
• • Intrahepatic cholangiocarcinoma
• • Uncontrolled infection
• • Concomitant malignancies or history of other malignancies in the previous 5 years