Study of Tislelizumab with S-1 for High-risk Recurrent Intrahepatic Cholangiocarcinoma after Surgery A Prospective, Multicenter Phase II Clinical Trial

What this Trial Is About

This clinical trial investigates the effectiveness and safety of combining Tislelizumab with S-1 in patients who have high-risk recurrent intrahepatic cholangiocarcinoma after radical surgery. The study focuses on individuals aged 18 to 75 years who have undergone complete or near-complete tumor removal but possess high-risk factors such as positive margins, multiple tumors, or vascular invasion. The goal is to evaluate treatment outcomes over a one-year period, including the rate of recurrence-free survival at 12 months. Participants receive Tislelizumab at a dose of 200 mg through intravenous infusion every three weeks for one year. Alongside this, S-1 is administered orally twice daily for four weeks followed by two weeks of rest, completing four treatment cycles. This combined regimen is designed to assess the potential benefits and safety profile of the two drugs administered together in this specific patient population. During the study, participants will undergo regular assessments including imaging scans and laboratory tests to monitor tumor status and organ function. Researchers will track treatment adherence, side effects, and overall health status. The primary outcome is the recurrence-free survival rate at one year. Continuous safety monitoring will be conducted throughout the study to ensure participant well-being and to collect comprehensive data on the treatment's impact.

Exploring the Efficacy and Safety of Tislelizumab in Combination With S-1 in the Treatment of Patients With Postoperative Recurrent High-risk Intrahepatic Cholangiocarcinoma