MedTrace Logo

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

NCT07424287 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2026-02-20

No results posted yet for this study

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 high-risk non-muscle-invasive bladder cancer (NMIBC).

Conditions

Interventions

DRUG

SHR-1501 for Injection

SHR-1501 for injection.

DRUG

BCG for Injection

Bacillus calmette guerin (BCG) for injection.

DRUG

Epirubicin Hydrochloride for Injection

Epirubicin hydrochloride for injection.

DRUG

Pirarubicin Hydrochloride for Injection

Pirarubicin hydrochloride for injection.

DRUG

Gemcitabine Hydrochloride for Injection

Gemcitabine hydrochloride for injection.

DRUG

Hydroxycamptothecin for Injection

Hydroxycamptothecin for injection.

DRUG

Mitomycin for Injection

Mitomycin for injection.

Sponsors & Collaborators

  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2030-06-30
Completion
2030-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07424287 on ClinicalTrials.gov