Efficacy and Safety of Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- side effect rate
研究概览
简要总结
To evaluate the efficacy and safety of tislelizumab combined with concurrent chemoradiotherapy in first-line treatment of stage IIIC2 cervical cancer.
详细描述
This is a multicenter, prospective, and randomized phase II clinical trial. Patients assigned to experimental group will receive standard radiotherapy with concomitant cisplatin 40mg/m2 once every week for 5 weeks, combined with tislelizumab (200 mg, day 1) once every 3 weeks until disease progression or intolerable toxicity occurs or one year. Patients assigned to control group will undergo standard radiotherapy with concomitant cisplatin 40mg/m2 once every week for 5 weeks. Compare the efficacy and toxicity of the two regimens in patients with stage IIIC2 cervical cancer.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 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
tislelizumab
The external radiation is administered at 45-50Gy/25f and brachytherapy is performed sequentially at 6Gy/time to a total doses of 30 Gy. The concomitant chemotherapy regimen is cisplatin 40mg/m2 on day 1 once every week for 5 weeks. In addition, patients also receive tislelizumab (200 mg, day 1) once every 3 weeks until disease progression or intolerable toxicity occurs or one year.
干预措施: tislelizumab (Drug)
concurrent chemoradiotherapy
The external radiation is administered at 45-50Gy/25f and brachytherapy is performed sequentially at 6Gy/time to a total doses of 30 Gy. The concomitant chemotherapy regimen is cisplatin 40mg/m2 on day 1 once every week for 5 weeks.
干预措施: concurrent chemoradiotherapy (Other)
结局指标
主要结局
side effect rate
时间窗: up to 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
3-year progress free survival rate
时间窗: up to 3 years
Progression-free survival (PFS) is defined as the time between entry into the study and progression of the tumor (in any respect) or death (from any cause).
次要结局
- Objective response rate(ORR)(3 months, after chemoradiotherapy)
- 3-year overall survival rate(up to 3 years)