A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-1501 for Injection, BCG for Injection, Epirubicin Hydrochloride for Injection, Pirarubicin Hydrochloride for Injection.
- Who it may be relevant to
- Registry conditions: NMIBC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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).
Interventions
- Drug SHR-1501 for Injection
SHR-1501 for injection. - Drug BCG for Injection
Bacillus calmette guerin (BCG) for injection. - Drug Epirubicin Hydrochloride for Injection
Epirubicin hydrochloride for injection. - Drug Pirarubicin Hydrochloride for Injection
Pirarubicin hydrochloride for injection. - Drug Gemcitabine Hydrochloride for Injection
Gemcitabine hydrochloride for injection. - Drug Hydroxycamptothecin for Injection
Hydroxycamptothecin for injection. - Drug Mitomycin for Injection
Mitomycin for injection.
Primary outcome measures
- Disease-Free Survival (DFS) assessed by Blinded Independent Central Review (BICR) [Time frame: Up to approximately 5 years.]
Secondary outcome measures (4)
- Disease-Free Survival (DFS) assessed by investigator [Time frame: Up to approximately 5 years.]
- Overall Survival (OS) [Time frame: Up to approximately 5 years.]
- Number of adverse events (AEs) as assessed by CTCAE v6.0. [Time frame: Up to approximately 5 years.]
- Number of serious adverse events (SAEs) as assessed by CTCAE v6.0. [Time frame: Up to approximately 5 years.]
Eligibility criteria
Inclusion criteria
- Aged at least 18 years, gender is not limited;
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
- Histologic confirmation of high-risk non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ); BCG-unresponsive;
- 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;
- Not suitable for or unwilling to undergo radical cystectomy;
- Sufficient hematology and organ function.
Exclusion criteria
- Previous histopathological diagnosis was muscle-invasive, locally advanced or metastatic urothelial carcinoma (T2 or T3 or T4 or N+ or M+);
- 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;
- 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;
- Those who have previously received immunostimulant therapy;
- 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;
- Previous medical history or examination suggests active tuberculosis within 1 year prior to the randomization.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Peking University First Hospital — Beijing
- Renji Hospital Affiliated to Shanghai Jiao Tong University School — Shanghai
Identifiers
NCT: NCT07424287 · SHR-1501-301