Phase II Study of Capecitabine and Yttrium-90 Selective Internal Radiation Therapy Before Surgery for Operable Intrahepatic Cholangiocarcinoma

What this Trial Is About

Researchers are evaluating a new treatment approach for patients with operable intrahepatic cholangiocarcinoma ICC, a challenging type of liver cancer. The study compares the standard surgery alone to a combination of chemotherapy with capecitabine and Selective Internal Radiation Therapy SIRT using Yttrium-90 microspheres before surgery. This phase II trial aims to improve surgical outcomes by reducing tumor size and increasing the likelihood of clear surgical margins, which are important for reducing recurrence risk. Participants are randomly assigned to one of two groups. The experimental group receives 12 weeks of capecitabine chemotherapy combined with SIRT, followed by surgery if the tumor remains resectable. SIRT treatment involves two stages performed under local anesthesia during a short hospital stay. The control group undergoes upfront surgery without prior treatment. If contraindications to SIRT are found after enrollment, patients stop chemotherapy and proceed directly to surgery. During the study, participants undergo CT scans and MRI to assess tumor status before surgery. After surgery, all patients are closely monitored every 3 months for 2 years, then every 6 months for an additional 3 years with clinical exams and imaging to check for disease progression. The main outcome measured is the frequency of patients achieving adequate surgical margins. The total study duration averages 5 years, with ongoing collection of vital status data even if disease progresses.

Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer