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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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 4, 2024 (before its estimated June 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT06441110
Lead Sponsor Fujian Medical University Union Hospital
Conditions
(from sponsor)		 Urinary Bladder Neoplasms, BCG Vaccine, Immunotherapy, Active, Multicenter Study, Treatment Outcome, Neoplasm Recurrence, Local
Related terms Motor Activity, Neoplasm Recurrence, Local, Urinary Bladder Neoplasms
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov