Shr-1501 plus BCG vs physician-chosen chemotherapy for BCG-unresponsive non-muscle invasive bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, open-label phase 3 trial comparing intravesical SHR-1501 plus BCG to investigator-selected chemotherapy in adults with high-risk, BCG-unresponsive NMIBC. Eligible participants have papillary, non-muscle invasive disease and are not candidates for immediate radical cystectomy. Outcomes focus on efficacy and safety, with procedures including intravesical injections of SHR-1501, BCG, and alternative chemotherapies such as epirubicin, pirarubicin, or gemcitabine. Key criteria require complete lesion removal on cystoscopy and adequate organ function, while exclusions cover prior muscle-invasive disease, recent surgeries, or prior systemic urothelial therapies. The trial is led by Suzhou Suncadia Biopharmaceuticals with sites in Beijing and Shanghai.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting
• Renji Hospital Affiliated to Shanghai Jiao Tong University School
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Wenliang Wang
• Email: wenliang.wang@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.