Study of Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin to Treat Advanced Biliary Tract Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new combination treatment for patients with advanced biliary tract cancer. This study focuses on combining standard chemotherapy drugs gemcitabine and cisplatin with two additional medications, adebrelimab and simvastatin. The main goal is to gather initial data on whether this four-drug combination is a promising approach for treating this advanced cancer type. All participants will receive the same treatment regimen, starting with up to 8 cycles of the combination therapy given every 21 days. This includes intravenous adebrelimab at 1200 mg on day 1 of each cycle, the standard chemotherapy drugs gemcitabine and cisplatin given intravenously, and daily oral simvastatin at 20 mg. After these initial cycles, patients will continue maintenance therapy with adebrelimab every 4 weeks and daily simvastatin until the cancer progresses or side effects become unacceptable. During the study, patients will be closely monitored through regular assessments to track tumor shrinkage, how long the treatment controls cancer growth, and any side effects experienced. The primary measure of success is the objective response rate, assessed up to about 2 years. Secondary measures include progression-free survival, overall survival, disease control rate, duration of response, and treatment-related adverse events. Safety and treatment effects will be followed for up to 3 years from enrollment.

Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin for Advanced Biliary Tract Cancer