Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer
Status:
Recruiting
Trial end date:
2026-02-04
Target enrollment:
Participant gender:
Summary
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.