Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After Selective Internal Radiotherapy With Labeled Yttrium and Chemotherapy: a Phase 2 Study
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.
• 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