RecruitingPhase 3NCT07424287

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)


Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

236 participants

Start Date

Jul 13, 2026

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BCG for Injection, a drug called Epirubicin Hydrochloride for Injection, and others for people with nmibc. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-1501 for Injection

SHR-1501 for injection.

DRUGBCG for Injection

Bacillus calmette guerin (BCG) for injection.

DRUGEpirubicin Hydrochloride for Injection

Epirubicin hydrochloride for injection.

DRUGPirarubicin Hydrochloride for Injection

Pirarubicin hydrochloride for injection.

DRUGGemcitabine Hydrochloride for Injection

Gemcitabine hydrochloride for injection.

DRUGHydroxycamptothecin for Injection

Hydroxycamptothecin for injection.

DRUGMitomycin for Injection

Mitomycin for injection.


Locations(2)

Peking University First Hospital

Beijing, Beijing Municipality, China

Renji Hospital Affiliated to Shanghai Jiao Tong University School

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT07424287


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