Study of Tislelizumab Combined With BCG Instillation to Prevent Recurrence in Intermediate and High-Risk Non-Muscle Invasive Bladder Cancer

What this Trial Is About

Researchers are investigating the combination of tislelizumab and Bacillus Calmette-Gurin BCG instillation as a treatment for intermediate and high-risk non-muscle invasive bladder cancer NMIBC. This Phase 3 clinical trial aims to explore the clinical effectiveness and safety of this combined therapy in reducing postoperative recurrence, addressing a gap in current research which has mostly been retrospective regarding PD-1PD-L1 inhibitors with BCG. Participants receive postoperative immediate instillation of epirubicin followed by intravenous tislelizumab every three weeks for one year. Additionally, eligible patients start BCG instillation two weeks after surgery, undergoing a 6-week induction phase of weekly BCG treatments, followed by three biweekly instillations, and then ten monthly maintenance instillations. This detailed regimen is designed to evaluate the combined treatments impact on cancer recurrence. Throughout the study, participants undergo regular postoperative cystoscopic and pathological examinations to monitor tumor recurrence and progression for up to 60 months. Researchers assess relapse-free survival as the primary outcome, alongside progression-free survival, overall survival, and adverse events. The study enrolls patients from multiple medical centers and includes extensive screening and follow-up to ensure safety and accurate evaluation of treatment effects.

Multicenter Clinical Trial on the Effectiveness and Safety of Instillation of BCG and Alternative BCG Protocols for Intermediate and High-risk Non-muscle Invasive Bladder Cancer