Phase 2 Study of Pembrolizumab Combined with Gemcitabine and Cisplatin Before and After Surgery for Treating Potentially Resectable Intrahepatic Cholangiocarcinoma

What this Trial Is About

Researchers are studying whether adding pembrolizumab to the standard chemotherapy drugs cisplatin and gemcitabine can improve long-term outcomes for patients with intrahepatic cholangiocarcinoma, a type of liver cancer, after surgery. This phase 2 single-arm study focuses on patients with high-risk but operable disease confined to the liver, bile duct, and regional lymph nodes. The research aims to evaluate recurrence-free survival and major pathological response, among other safety and efficacy markers. Participants will receive four cycles of combined chemotherapy with pembrolizumab, gemcitabine, and cisplatin, each cycle lasting 21 days, administered intravenously before and after their scheduled surgery. Clinic visits occur every three weeks during the approximately nine months of chemotherapy treatment. After this treatment phase, participants will be followed up regularly every three months for 2 to 4 years to monitor their health and disease status. Throughout the study, participants will undergo assessments including imaging scans, laboratory tests, and biomarker analyses to evaluate treatment response, immune effects, and safety. Researchers will track adverse events using standard criteria and monitor outcomes such as overall survival and progression-free survival. Additional studies will explore immune responses and microbiome changes before and after treatment. Total participation may last several years, encompassing treatment and extended follow-up.

A Single-Arm Study of Pembrolizumab With Gemcitabine and Cisplatin as Perioperative Therapy for Potentially Resectable Intrahepatic Cholangiocarcinoma