Phase II Study of Camrelizumab with Gemcitabine and Oxaliplatin for Unresectable Gallbladder Cancer Evaluating Effectiveness and Safety in Adults Aged 18 to 75

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining Camrelizumab with gemcitabine and oxaliplatin GEMOX chemotherapy for patients with unresectable gallbladder cancer. This single-arm Phase II trial aims to assess how well this treatment approach works to shrink tumors enough to allow surgery and to monitor patients overall disease control and survival. The study is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University and expects to enroll 37 patients. Participants receive Camrelizumab at a dose of 200 mg by intravenous infusion on day 1, along with gemcitabine 1000 mgm2 and oxaliplatin 100 mgm2, also given intravenously on day 1. These treatments are given together every 21 days, making one course, for a total of 6 to 8 courses. Tumor markers are tested at each course, and abdominal CT angiography is performed every two courses to check tumor status until progression occurs. During the study, patients undergo regular assessments including blood tests for tumor markers and imaging scans to monitor tumor response. The main outcome measured is the rate of radical tumor removal after treatment. Secondary outcomes include disease control rate, objective response rate, progression-free survival, and overall survival, all assessed at 6 months. Safety is closely monitored by recording any side effects or serious adverse events. Participants are followed throughout the treatment cycles until the tumor progresses or treatment ends.

A Single-arm Phase II Clinical Study of the Efficacy and Safety of Camrelizumab Combined With GEMOX for Unresectable GBCs