A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC

Prior treatment

• Previous histopathological diagnosis was muscle-invasive, locally advanced or metastatic urothelial carcinoma (T2 or T3 or T4 or N+ or M+).
• Received surgery such as TURBT or radiotherapy for bladder lesions within 2 weeks before the randomization; Major surgery was performed within 28 days before randomization;
• Those who have previously received immunostimulant therapy or immune checkpoint inhibitors;
• Those who have previously received intravesical instillation of cytotoxic chemotherapy and have not experienced disease recurrence or progression before enrolment as assessed by investigator;
• Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;
• Previous medical history or examination suggests active tuberculosis within 1 year prior to the randomization;

Other

• Those who plan to undergo radical (partial) cystectomy during the study;

• Aged at least 18 years, gender is not limited;
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
• Histologic confirmation of high-riskpapillary-only non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ);
• No previous BCG therapy;
• Cystoscopy within 6 weeks before the randomization shows that the lesion has been completely removed; for T1 stage lesions, pathological results must show the presence of bladder muscle tissue;
• Sufficient hematology and organ function;