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

May 29, 2026 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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)

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

236

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
        • Principal Investigator:
          • Zhisong He
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200120
        • Renji Hospital Affiliated to Shanghai Jiao Tong University School
        • Principal Investigator:
          • Wei Xue
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged at least 18 years, gender is not limited;
  2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
  3. Histologic confirmation of high-risk non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ); BCG-unresponsive;
  4. Cystoscopy within 6 weeks before the randomization shows that the lesion has been completely removed; for T1 stage lesions, pathological results must show the presence of bladder muscle tissue;
  5. Not suitable for or unwilling to undergo radical cystectomy;
  6. Sufficient hematology and organ function.

Exclusion Criteria:

  1. Previous histopathological diagnosis was muscle-invasive, locally advanced or metastatic urothelial carcinoma (T2 or T3 or T4 or N+ or M+);
  2. Received surgery such as TURBT or radiotherapy for bladder lesions within 2 weeks before the randomization; Major surgery was performed within 28 days before randomization;
  3. Those who have previously received the following treatments and have not experienced disease recurrence or progression before enrolment: a) Intravesical infusion of cytotoxic chemotherapy or other drugs (such as oncolytic viruses), etc; b) Immune checkpoint inhibitors; c) Other investigatory drugs for the treatment of NMIBC;
  4. Those who have previously received immunostimulant therapy;
  5. Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;
  6. Previous medical history or examination suggests active tuberculosis within 1 year prior to the randomization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-1501 + BCG Group
SHR-1501, Bacillus Calmette Guerin (BCG).
Drug: SHR-1501 for Injection
SHR-1501 for injection.
Drug: BCG for Injection
Bacillus calmette guerin (BCG) for injection.
Active Comparator: Investigator-selected Chemotherapy Group
Epirubicin or Pirarubicin or Gemcitabine or Hydroxycamptothecin or Mitomycin.
Drug: Gemcitabine Hydrochloride for Injection
Gemcitabine hydrochloride for injection.
Drug: Epirubicin Hydrochloride for Injection
Epirubicin hydrochloride for injection.
Drug: Pirarubicin Hydrochloride for Injection
Pirarubicin hydrochloride for injection.
Drug: Hydroxycamptothecin for Injection
Hydroxycamptothecin for injection.
Drug: Mitomycin for Injection
Mitomycin for injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival (DFS) assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 5 years.
Disease free survival is defined as the time from randomization to date of DFS event assessed by BICR.
Up to approximately 5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 5 years.
Overall Survival (OS) is defined as the time from randomization to date of death from any cause.
Up to approximately 5 years.
Number of adverse events (AEs) as assessed by CTCAE v6.0.
Time Frame: Up to approximately 5 years.
Up to approximately 5 years.
Number of serious adverse events (SAEs) as assessed by CTCAE v6.0.
Time Frame: Up to approximately 5 years.
Up to approximately 5 years.
Disease-Free Survival (DFS) assessed by investigator
Time Frame: Up to approximately 5 years.
Disease-free survival (DFS) is defined as the time from randomization to date of DFS event assessed by investigator.
Up to approximately 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-1501-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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