Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy
NCT06910722
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 (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.
Eligibility
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
Conditions4
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NCT06910722