Liver Transplantation After Selective Internal Radiotherapy and Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma A Phase 2 Study Evaluating 3-Year Survival in Patients Unfit for Surgery

What this Trial Is About

This research aims to evaluate whether liver transplantation following selective internal radiation therapy SIRT and chemotherapy can improve the three-year overall survival rate for patients with locally advanced intrahepatic cholangiocarcinoma. The study targets patients with unresectable but non-metastatic tumors who are not suitable for initial surgery. The trial is supported by a panel of experts and involves participants recruited from care centers in France. Participants will undergo SIRT using Yttrium-90 combined with chemotherapy drugs gemcitabine and cisplatin. After this treatment phase, tumor response will be assessed using CT scans, hepatic MRI, and PET-CT to confirm no disease progression. Patients passing this evaluation will have exploratory surgery to exclude contraindications before being placed on the liver transplant waiting list, with a minimum wait time of three months. The transplantation will then be performed, followed by immunosuppressive therapy. Throughout the study, participants will be closely monitored for liver graft function and how well they tolerate immunosuppressive treatment. Follow-up will include evaluations of overall survival at three years post-transplant, along with assessments of therapeutic efficacy, quality of life, and treatment tolerance over multiple years. The total participation duration covers induction therapy through five years after transplantation to fully capture long-term outcomes and safety.

Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy