A Phase 3 interventional study of SHR-1501 for Injection and BCG for Injection in NMIBC, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Phase 3, Interventional, and Treatment
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).
265 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 113 are open to participants now.
This study's planned enrollment of 236 is above the median of 70 across 204 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Browse Non-Muscle Invasive Bladder Neoplasms studies →Suzhou Suncadia Biopharmaceuticals Co., Ltd. is the lead sponsor of 100 studies on the registry; 69 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SHR-1501, Bacillus Calmette Guerin (BCG).
Drug: SHR-1501 for Injection · Drug: BCG for Injection
Epirubicin or Pirarubicin or Gemcitabine or Hydroxycamptothecin or Mitomycin.
Drug: Epirubicin Hydrochloride for Injection · Drug: Pirarubicin Hydrochloride for Injection · Drug: Gemcitabine Hydrochloride for Injection · Drug: Hydroxycamptothecin for Injection · Drug: Mitomycin for Injection
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.
Disease-Free Survival (DFS) assessed by Blinded Independent Central Review (BICR)
Disease free survival is defined as the time from randomization to date of DFS event assessed by BICR.
Time frame: Up to approximately 5 years.
Disease-Free Survival (DFS) assessed by investigator
Disease-free survival (DFS) is defined as the time from randomization to date of DFS event assessed by investigator.
Time frame: Up to approximately 5 years.
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization to date of death from any cause.
Time frame: Up to approximately 5 years.
Number of adverse events (AEs) as assessed by CTCAE v6.0.
Time frame: Up to approximately 5 years.
Number of serious adverse events (SAEs) as assessed by CTCAE v6.0.
Time frame: Up to approximately 5 years.
Plan to share: Undecided
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Non-Muscle Invasive Bladder Neoplasms→
Suzhou Suncadia Biopharmaceuticals Co., Ltd.