Status:
NOT_YET_RECRUITING
Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Liver Transplantation in Locally Advanced Intrahepatic Cholangiocarcinoma
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 (unresecta...
Detailed Description
The hypothesis of the study is that liver transplantation after selective internal radiation therapy (SIRT) and chemotherapy would improve the overall 3-year survival of patients with locally advanced...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2030
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06910722
Start Date
April 1 2025
End Date
April 1 2030
Last Update
April 4 2025
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