A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC
Starting soon · Phase 3 · Has a placebo group
Conditions studied: Papillary-Only Non-muscle-invasive Bladder Cancer
In brief
This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with high-risk BCG-naive Papillary-Only non-muscle-invasive bladder cancer (NMIBC)
Key facts
- Study ID
- NCT07726992
- Run by
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- People needed
- 750
- Starts
- 2026-07-01
- Expected to finish
- 2030-08-01
- Last updated by the study team
- 2026-07-27
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-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;
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 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;
- Those who plan to undergo radical (partial) cystectomy during the study;
- 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
- The First Medical Center of the Chinese People's Liberation Army General Hospital — Beijing, Beijing Municipality, China
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
Full record on ClinicalTrials.gov
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