Clinical Research Directory

Inclusion Criteria: 1. Aged at least 18 years, gender is not limited; 2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2; 3. Histologic confirmation of high-risk non-muscle invasive bladder cancer; BCG-unresponsive; 4. 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; 5. Not suitable for or unwilling to undergo radical cystectomy; 6. Sufficient hematology and organ function. Exclusion Criteria: 1. Previous histopathological diagnosis was muscle-invasive, locally advanced or metastatic urothelial carcinoma (T2 or T3 or T4 or N+ or M+); 2. 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; 3. Those who have previously received the following treatments and have not experienced disease recurrence or progression before enrolment: a) Intravesical infusion of cytotoxic chemotherapy or other drugs (such as oncolytic viruses), etc; b) Immune checkpoint inhibitors; c) Other investigatory drugs for the treatment of NMIBC; 4. Those who have previously received immunostimulant therapy; 5. 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; 6. Previous medical history or examination suggests active tuberculosis within 1 year prior to the randomization.