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

Treatment of intrahepatic cholangiocarcinoma (ICC) remains difficult. Many patients have unresectable tumors, and survival after resection was only slightly improved with the use of adjuvant capecitabine. One of the major prognostic factors is the resection margin, patients with invaded (R1) or narrow (\<5mm) margins having a higher risk of recurrence. Selective Internal Radiation Therapy (SIRT) with Yttrium-90 microspheres (also known as SIRT) is an interesting treatment in unresectable ICC. In a phase 2 study, the investigators showed a response rate of 39% and a disease control rate of 98%. Interestingly, 9 of the 41 patients were able to see their tumors downstages to surgery. It was also recently suggested in a retrospective study that patients resected after SIRT had a better prognosis than patients that could be operated upfront, despite less favorable initial tumor characteristics. Given the absence of validated neoadjuvant treatment, the promising activity of SIRT and chemotherapy combination in the unresectable setting, and the prognostic significance of close surgical margins, the aim of this trial is therefore to study this combination treatment in the neoadjuvant setting of resectable ICC.

NCT Number	NCT05265208
Lead Sponsor	Center Eugene Marquis
Conditions	Resectable Intrahepatic Cholangiocarcinoma
Enrollment	62 participants
Start Date	2022-02-04
Primary Completion	2027-09-04 (estimated)
Study Completion	2030-02-04 (estimated)
Updated on ClinicalTrials.gov	2025-08-06