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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- Event-Free Survival (EFS)
研究概览
简要总结
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).
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
- None
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-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.
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 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.
研究组 & 干预措施
Investigator-selected Chemotherapy Group
Epirubicin or Pirarubicin or Gemcitabine or Hydroxycamptothecin or Mitomycin.
干预措施: Gemcitabine Hydrochloride for Injection (Drug)
SHR-1501 + BCG Group
SHR-1501, Bacillus Calmette Guerin (BCG).
干预措施: SHR-1501 for Injection (Drug)
SHR-1501 + BCG Group
SHR-1501, Bacillus Calmette Guerin (BCG).
干预措施: BCG for Injection (Drug)
Investigator-selected Chemotherapy Group
Epirubicin or Pirarubicin or Gemcitabine or Hydroxycamptothecin or Mitomycin.
干预措施: Pirarubicin Hydrochloride for Injection (Drug)
Investigator-selected Chemotherapy Group
Epirubicin or Pirarubicin or Gemcitabine or Hydroxycamptothecin or Mitomycin.
干预措施: Hydroxycamptothecin for Injection (Drug)
Investigator-selected Chemotherapy Group
Epirubicin or Pirarubicin or Gemcitabine or Hydroxycamptothecin or Mitomycin.
干预措施: Mitomycin for Injection (Drug)
Investigator-selected Chemotherapy Group
Epirubicin or Pirarubicin or Gemcitabine or Hydroxycamptothecin or Mitomycin.
干预措施: Epirubicin Hydrochloride for Injection (Drug)
结局指标
主要结局
Event-Free Survival (EFS)
时间窗: Up to approximately 5 years.
Event free survival is defined as the time from randomization to date of EFS event.
次要结局
- Complete response (CR) rate(Up to approximately 5 years.)
- Duration of Response (DoR)(Up to approximately 5 years.)
- Disease-Free Survival (DFS)(Up to approximately 5 years.)
- Overall Survival (OS)(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.)