Papillary-Only Non-muscle-invasive Bladder Cancer
Conditions
Brief summary
This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with high-risk BCG-naive Papillary-Only non-muscle-invasive bladder cancer (NMIBC)
Interventions
DRUGSHR-1501+BCG
SHR-1501+BCG
DRUGPlacebo +BCG
Placebo +BCG
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-Free Survival (DFS) assessed by BICR: Disease-free survival is defined as the time from randomization to date of DFS event assessed by BICR. | Up to approximately 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Disease-Free Survival (DFS) assessed by investigator: Disease-free survival is defined as the time from randomization to date of DFS event assessed by investigator. | Up to approximately 5 years |
| Overall Survival (OS): Overall Survival defined as the time from randomization to the date of death from any cause. | Up to approximately 5 years. |
| Number of adverse events (AEs) as assessed by CTCAE v6.0. | Up to approximately 5 years. |
| Number of serious adverse events (SAEs) as assessed by CTCAE v6.0. | Up to approximately 5 years. |
Countries
China
Contacts
CONTACTWenliang Wang
CONTACTQi Zhang
Outcome results
None listed