SHR-1501 with BCG compared with chemotherapy for bladder cancer not helped by BCG
Compares SHR-1501 plus BCG with chemotherapy in non-muscle-invasive bladder cancer that BCG no longer controls.
Plain-language title generated from the registry record
Registry title: A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC
Key facts
- Where
- Beijing and Shanghai, ChinaSee the 2 sites
- Phase
- Phase 3
Where in China
- Peking University First HospitalBeijing, ChinaTaking people
- Renji Hospital Affiliated to Shanghai Jiao Tong University SchoolShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Trial code
- NCT07424287
- Record updated
- 20 July 2026
- Original description
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).Read full original descriptionShow less
A Multicenter, Randomized, Open-label Phase III Clinical Study 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) (NiBladder 1)
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).
Inclusion: 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.
Exclusion: 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.