A Phase III, Randomized, Open-label, Active Controlled, Multicenter Study on Toripalimab Combined With Axitinib Versus Sunitinib Monotheraphy as a First-Line Treatment for Unresectable or Metastatic Renal Cell Carcinoma (RCC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 421
- 试验地点
- 1
- 主要终点
- PFS assessed by IRC per RECIST 1.1.
研究概览
简要总结
This is a randomized, open-label, controlled, multicenter, phase III trial to compare the efficacy and safety of Toripalimab in combination with axitinib to sunitinib monotherapy as a first-line therapy for advanced RCC. Eligible patients will be randomized 1:1 to receive the combination therapy of Toripalimab and axitinib or sunitinib monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Control group
Sunitinib monotherapy. Participants receive sunitinib 50mg orally once daily for 4 weeks and then are off treatent for 2 weeks, or once daily for 2weeks and then are off treatent for 1 week.
干预措施: sunitinib (Drug)
结局指标
主要结局
PFS assessed by IRC per RECIST 1.1.
时间窗: 3 years
To compare the progression-free survival (PFS) per response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by independent review committee (IRC) in subjects treated with Toripalimab plus axitinib vesus sunitinib monotherapy as a first-line treatment for advanced RCC.
次要结局
- Incidence and grade of AEs and SAEs per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, incidence of ≥ grade 3 AE;(3 years)
- OS assessed by investigators and IRC per RECIST 1.1, respectively;(3 years)
- DOR, assessed by investigators and IRC per RECIST 1.1, respectively;(3 years)
- DCR assessed by investigators and IRC per RECIST 1.1, respectively;(3 years)
- overall survival rate assessed by investigators and IRC per RECIST 1.1, respectively;(3 years)
- PFS assessed by investigators per RECIST 1.1;(3 years)
- ORR assessed by investigators and IRC per RECIST 1.1, respectively;(3 years)
- Incidence and grade of AEs and SAEs related to study drugs per NCI-CTCAE version 5.0, AEs ≥ grade 3 related to the study drugs.(3 years)