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A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC

NCT07726992 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2026-07-27

No results posted yet for this study

Summary

This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with high-risk BCG-naive Papillary-Only non-muscle-invasive bladder cancer (NMIBC)

Conditions

  • Papillary-Only Non-muscle-invasive Bladder Cancer

Interventions

DRUG

SHR-1501+BCG

SHR-1501+BCG

DRUG

Placebo +BCG

Placebo +BCG

Sponsors & Collaborators

  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2029-12-31
Completion
2030-08-31

Countries

  • China

Study Locations

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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 NCT07726992 on ClinicalTrials.gov