Actively Recruiting
Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-06
36
Participants Needed
1
Research Sites
474 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study hypothesis is that liver transplantation after selective internal radiation therapy (SIRT) and chemotherapy would improve 3-year overall survival in patients with locally advanced (unresectable but non-metastatic) intrahepatic cholangiocarcinoma. It is planned to include 36 patients with locally advanced intrahepatic cholangiocarcinoma, not eligible for initial surgery and without metastases. Participants will be recruited from care facilities in France.
CONDITIONS
Official Title
Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 to 65
- Histologically confirmed intrahepatic cholangiocarcinoma with one to five tumors
- No spread outside the liver or to lymph nodes
- Tumor considered technically unresectable by expert panel
- Tumor size larger than 2 cm
- WHO performance status 0 or 1
- Signed informed consent
- Use of effective contraception during the study and for up to 2 years after treatment
You will not qualify if you...
- Extrahepatic, vesicular, or perihilar cholangiocarcinoma
- Tumor affecting more than 50% of the liver
- Mixed tumor types including hepatocellular or fibrolamellar carcinoma
- Previous treatment for cholangiocarcinoma
- Cirrhosis classified as Child B7 or higher
- Chronic alcoholism
- Uncontrolled chronic active infections (controlled HBV, HCV, or HDV allowed)
- Chronic kidney failure stage III A or worse (glomerular filtration rate below 59 ml/min)
- Contraindications to liver transplant including severe untreatable conditions, recent cancer history less than 5 years ago, severe comorbidities, psychiatric or psychological disorders
- Pregnant or breastfeeding women
- Patients under legal guardianship
- Not affiliated with a health care system
- Participation in another interventional study or within exclusion period of a previous study involving human subjects
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beaujon
Clichy-sous-Bois, France
Actively Recruiting
Research Team
M
Mohamed BOUATTOUR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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