NCT07726992招募中3 期
A Multicenter, Randomized, Double-blind Phase III Study 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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 4
- 主要终点
- 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.
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged at least 18 years, gender is not limited;
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
- •Histologic confirmation of high-riskpapillary-only non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ);
- •No previous BCG therapy;
- •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;
- •Sufficient hematology and organ function;
排除标准
- •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 immunostimulant therapy or immune checkpoint inhibitors;
- •Those who have previously received intravesical instillation of cytotoxic chemotherapy and have not experienced disease recurrence or progression before enrolment as assessed by investigator;
- •Those who plan to undergo radical (partial) cystectomy during the study;
- •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;
研究组 & 干预措施
SHR-1501+BCG
Experimental
干预措施: SHR-1501+BCG (Drug)
Placebo +BCG
Placebo Comparator
干预措施: Placebo +BCG (Drug)
结局指标
主要结局
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.
时间窗: Up to approximately 5 years
次要结局
- 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.)
- 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)
研究者
研究点 (4)
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