Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 28, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether liver transplantation can help patients with a specific type of liver cancer called intrahepatic cholangiocarcinoma, which is advanced but hasn't spread to other parts of the body. The study will include 36 patients who cannot have surgery to remove their tumors and who have already undergone treatment with selective internal radiation therapy (SIRT) and chemotherapy. Researchers hope that this approach will lead to better survival rates after three years compared to standard treatments alone.

To be eligible for this trial, participants need to be between 18 and 65 years old and have a confirmed diagnosis of intrahepatic cholangiocarcinoma with a limited number of tumors. They should not have tumors that have spread outside the liver or significant liver damage (like cirrhosis). Participants will need to provide informed consent and agree to use effective contraception if they are of childbearing age. While the trial is not currently recruiting, it will take place in care facilities in France. Participants can expect to receive close monitoring and support throughout the study to ensure their safety and well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient aged 18 to 65
• * With histologically documented intrahepatic cholangiocarcinoma (primary diagnosis):
• • Uni or pauci nodular (≤ 5 lesions (all lesions are counted, even those less than 1 cm))
• • Without extrahepatic or lymph node involvement
• • Technically unresectable R0 according to an expert panel
• • Tumor target \> 2 cm
• • WHO 0-1
• • free and informed consent signed
• • highly effective contraception for men and women of childbearing age during study participation up to 2 years post TH
• Exclusion Criteria:
• • Extrahepatic, vesicular or perihilar cholangiocarcinoma
• • Tumor infiltration of more than 50% of the liver
• • Mixed cholangiocarcinoma, hepatocellular carcinoma, fibrolamellar carcinoma
• • Previous treatment for CCI
• • Cirrhosis ≥ Child B7
• • Chronic alcoholism
• • Uncontrolled chronic active infections (patients with HBV, HCV or HDV infections may be included if infections are controlled)
• • Stage III A, IIIB, IV and V chronic renal failure (glomerular filtration rate 59 ml/min)
• • Contraindications to liver transplant
• • Severe untreatable conditions
• • Recent history (less than 5 years) of cancer
• • severe comorbidities
• • Psychiatric or psychological disorders
• • Pregnant or breast-feeding women
• • Patient under guardianship
• • Not affiliated to a Health care system
• • Participating in another interventional study or within the exclusion period of a previous study involving the human body