drugset / Trial / NCT06441110

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

NCT06441110

Phase 3 Recruiting 76 enrolled Fujian Medical University Union Hospital
NaSingle-groupOpen-labelTreatment

Summary

Previous studies have reported the efficacy of Bacillus Calmette-Guérin (BCG) combined with other drugs for the treatment of bladder cancer. However, research on the combination of tislelizumab and BCG for bladder cancer treatment has largely been retrospective. Currently, ongoing clinical trials have not discussed the effectiveness of PD-1/PD-L1 inhibitors combined with BCG instillation in reducing postoperative recurrence in intermediate-risk NMIBC. Therefore, this study aims to explore the clinical efficacy and safety of tislelizumab combined with BCG in the treatment of intermediate and high-risk NMIBC. For this purpose, investigators have established strict screening criteria to include eligible patients in the study and have recruited suitable patients from multiple medical centers.Investigators have also developed a meticulous implementation process and follow-up considerations, hoping to better verify the clinical efficacy and safety of the combined use of these two drugs.

Timeline

Start
2023-06-01
Primary completion
2025-06-01
Completion
2035-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bacillus Calmette-Guérin Vaccine 120 mg Other
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous
Background Epirubicin Small molecule 50 mg Other