OncoMatch/Clinical Trials/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
Is NCT06441110 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Tislelizumab in Combination with Bacillus Calmette-Guérin for urinary bladder neoplasms.
Treatment: Tislelizumab in Combination with Bacillus Calmette-Guérin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) positive expression (positive)
positive PD-L1 expression
Disease stage
Required: Stage NON-MUSCLE-INVASIVE (2014 guidelines of the Chinese Urological Association (CUA))
Excluded: Stage T2 AND ABOVE
non-muscle-invasive bladder urothelial carcinoma; muscle-invasive bladder urothelial carcinoma (stage T2 and above) patients [excluded]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Exception: immediate postoperative bladder instillation chemotherapy
Patients who have received chemotherapy, radiotherapy, or immunotherapy within the past 4 weeks (except immediate postoperative bladder instillation chemotherapy)
Cannot have received: radiotherapy
Patients who have received chemotherapy, radiotherapy, or immunotherapy within the past 4 weeks (except immediate postoperative bladder instillation chemotherapy)
Cannot have received: immunotherapy
Patients who have received chemotherapy, radiotherapy, or immunotherapy within the past 4 weeks (except immediate postoperative bladder instillation chemotherapy)
Lab requirements
Blood counts
complete blood count required; severe hematopoietic function disorder excluded
Kidney function
kidney function screening required; severe chronic kidney disease excluded
Liver function
liver function screening required; severe liver function disorder excluded
Cardiac function
severe chronic cardiovascular or cerebrovascular diseases excluded; 12-lead ECG required
Completion of screening-related examinations (complete blood count, coagulation function, liver and kidney function, infectious disease screening, 12-lead ECG, urinary system ultrasound, pelvic MR, and tissue pathology examination), without surgical contraindications. Exclusion: severe chronic cardiovascular or cerebrovascular diseases or chronic kidney disease; severe coagulation function, liver and kidney function, hematopoietic function disorders, etc., that cannot tolerate surgical treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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