A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC

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).

Trial Details

NCT ID
NCT07424287
Phase
PHASE3
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • SHR-1501 for Injection
  • BCG for Injection
  • Epirubicin Hydrochloride for Injection
  • Pirarubicin Hydrochloride for Injection
  • Gemcitabine Hydrochloride for Injection
  • Hydroxycamptothecin for Injection
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • 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 mu…

For full eligibility, visit ClinicalTrials.gov.

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