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

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.

NCT Number	NCT06441110
Lead Sponsor	Fujian Medical University Union Hospital
Conditions	Urinary Bladder Neoplasms, BCG Vaccine, Immunotherapy, Active, Multicenter Study, Treatment Outcome, Neoplasm Recurrence, Local
Enrollment	76 participants
Start Date	2023-06-01
Primary Completion	2025-06-01 (estimated)
Study Completion	2035-06-01 (estimated)
Updated on ClinicalTrials.gov	2024-06-04