Preventing Liver Cancer Return After Surgery for Intrahepatic Cholangiocarcinoma Using a Chemo Pump with Floxuridin

What this Trial Is About

Researchers are evaluating whether adding chemotherapy through a chemo pump directly into the liver can prevent the return of bile duct cancer within the liver after surgery. This study focuses on adults with intrahepatic bile duct cancer that can be treated by surgery. The main goals are to see if this additional chemotherapy reduces cancer recurrence in the liver within two years, improves overall survival, and affects quality of life. Participants will undergo surgery to remove the cancer, followed by implantation of a chemo pump. This pump delivers four cycles of chemotherapy with floxuridin directly to the liver, each cycle lasting four weeks, for a total chemotherapy duration of about sixteen weeks. The study period includes monitoring during and after treatment to assess outcomes. During the study, participants will be closely monitored for cancer recurrence in the liver and elsewhere, survival status, and quality of life using specific questionnaires. Researchers will also track post-operative complications and chemotherapy side effects. Biomarkers from blood and liver tissue will be collected to understand treatment effects, and cost-effectiveness will be evaluated. The study follow-up can last up to five years, with some biomarker evaluations extending up to 25 years according to regulations.

Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery