Unresectable intrahepatic cholangiocarcinoma (ICC) is a type of cancer that develops in the cells within the bile ducts. Selective internal radiotherapy (SIRT) has emerged as a promising treatment option for hepatic tumors, but its efficacy with chemotherapy has not been studied. This study aims to evaluate the response rate of SIRT combined with chemotherapy in patients with unresectable ICC.
This phase-2 clinical trial included a total of 41 patients with unresectable ICC who had never received chemotherapy or intra-arterial therapy before. The patients were assigned to receive concomitant first-line chemotherapy with cisplatin and gemcitabine on days one and eight of eight 21-day cycles. The primary outcome of the study was the response rate at 3 months, along with toxic effects, progression-free survival, and overall survival.
The response rate of the intervention was 39% at 3 months, along with a disease control rate of 98%. At a median follow-up of 36 months, the progression-free survival rates were 55% at 12 months and 30% at 24 months. The median overall survival was 22 months, with overall survival rates of 75% and 45% at 12 months and 24 months, respectively. The research concluded that concomitant chemotherapy with SIRT resulted in a substantial portion of patients being downstaged to surgical intervention.