A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC
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)
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
236 participants
Jul 13, 2026
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
SHR-1501 for injection.
Bacillus calmette guerin (BCG) for injection.
Epirubicin hydrochloride for injection.
Pirarubicin hydrochloride for injection.
Gemcitabine hydrochloride for injection.
Hydroxycamptothecin for injection.
Mitomycin for injection.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07424287