A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC
Recruiting now · Phase 3
Conditions studied: NMIBC
In brief
This is a multicenter, randomized, open-label phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus investigator-selected chemotherapy in patients with BCG-unresponsive papillary-only non-muscle-invasive bladder cancer (NMIBC).
Key facts
- Study ID
- NCT07424287
- Run by
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- People needed
- 236
- Starts
- 2026-07-13
- Expected to finish
- 2030-06-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged at least 18 years, gender is not limited;
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
- Histologic confirmation of high-risk non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ); BCG-unresponsive;
- 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;
- Not suitable for or unwilling to undergo radical cystectomy;
- Sufficient hematology and organ function.
You may not qualify if…
- 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 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;
- Those who have previously received immunostimulant therapy;
- 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.
Where it is running
- Peking University First Hospital — Beijing, Beijing Municipality, China (enrolling)
- Renji Hospital Affiliated to Shanghai Jiao Tong University School — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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