NCT07424287 A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC
| NCT ID | NCT07424287 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | NMIBC |
| Study Type | INTERVENTIONAL |
| Enrollment | 236 participants |
| Start Date | 2026-07-13 |
| Primary Completion | 2030-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 236 participants in total. It began in 2026-07-13 with a primary completion date of 2030-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 papillary-only non-muscle-invasive bladder cancer (NMIBC).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07424287 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NMIBC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07424287 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 236 participants.
Is NCT07424287 currently recruiting?
Yes, NCT07424287 is actively recruiting participants. Contact the research team at wenliang.wang@hengrui.com for enrollment information.
Where is the NCT07424287 trial being conducted?
This trial is being conducted at Beijing, China, Shanghai, China.
Who is sponsoring the NCT07424287 clinical trial?
NCT07424287 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 236 participants.