Shr-1501 plus BCG vs placebo plus BCG in high-risk papillary-only NMIBC

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 multicenter, randomized, double-blind phase 3 study compares intravesical SHR-1501 plus BCG to placebo plus BCG in adults with high-risk papillary-only NMIBC who have not received BCG before. Eligible participants have non-muscle-invasive tumors that are high-grade Ta or T1, with complete tumor removal confirmed within 6 weeks and adequate organ function. Key exclusions include previous muscle-invasive disease, recent surgery or radiotherapy, and prior immunotherapy. The trial is sponsored by Suzhou Suncadia Biopharmaceuticals with two leading Chinese centers participating. Primary outcomes focus on efficacy and safety of adding SHR-1501 to standard BCG therapy.

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-riskpapillary-only non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ);
4. No previous BCG therapy;
5. 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;
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 immunostimulant therapy or immune checkpoint inhibitors;
4. Those who have previously received intravesical instillation of cytotoxic chemotherapy and have not experienced disease recurrence or progression before enrolment as assessed by investigator;
5. Those who plan to undergo radical (partial) cystectomy during the study;
6. 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;
7. Previous medical history or examination suggests active tuberculosis within 1 year prior to the randomization;

Where it's running

• The First Medical Center of the Chinese People's Liberation Army General Hospital
  Beijing, Beijing Municipality, China Recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Wenliang Wang
• Email: wenliang.wang@hengrui.com
• Phone: 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.