Phase II Study of Postoperative Chemoradiotherapy with Integrated Boost After Liver Surgery for Intrahepatic Cholangiocarcinoma with Narrow Margin or Lymph Node Involvement

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a combined chemotherapy and radiotherapy treatment after liver surgery for patients with intrahepatic cholangiocarcinoma who have narrow surgical margins or lymph node involvement. This phase II trial focuses on patients who have had a hepatectomy and aims to improve disease-free survival and overall outcomes over two years. Participants will receive advanced radiation therapy techniques, either IMRT or VMAT, targeting high-risk tumor areas with a higher dose and lymphatic regions with a moderate dose across 20-25 sessions. During radiation, patients take capecitabine tablets for two cycles, followed by maintenance capecitabine for six cycles. If capecitabine is not tolerated, an alternative drug, S-1, will be used instead. Throughout the study, participants will be closely monitored for recurrence of cancer, overall survival, tumor control in the treated area, and any severe side effects. Assessments include imaging such as MRI and PET-CT scans before treatment to rule out distant cancer spread. The study tracks outcomes for up to two years to understand the treatments impact and safety. Participants must have a good performance status and expected survival over three months to join.

A Prospective Phase II Study of Postoperative Concurrent Chemoradiotherapy in Patients With Intrahepatic Cholangiocarcinoma