NCT07167160招募中2 期
Camrelizumab Combined With Chemotherapy for Adjuvant Treatment of Cervical Cancer Patients With Pathologically Confirmed Lymph Node Positivity After Stage Surgery: A Prospective, Single-Arm, Multicenter, Phase II Clinical Trial
Women's Hospital School Of Medicine Zhejiang University1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2025年3月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- 3-year disease-free survival rate
研究概览
简要总结
Efficacy evaluation of camrelizumab combined with chemotherapy for adjuvant treatment of patients with pathologically confirmed lymph node-positive cervical cancer after staging surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with cervical cancer staged FIGO2018 IIIC1p or IIIC2p after radical surgery;
- •Positive PD-L1 expression;
- •ECOG score ≤1
排除标准
- •Positive parametrium or surgical margin;
- •Incomplete radical surgery;
- •Residual target lesions;
- •Active autoimmune disease or autoimmune disease requiring systemic treatment;
- •Previous treatment with immune checkpoint inhibitors.
研究组 & 干预措施
chemotherapy group
Experimental
干预措施: Camrelizumab combined with chemotherapy (Drug)
结局指标
主要结局
3-year disease-free survival rate
时间窗: from enrollment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 100 months
次要结局
未报告次要终点
研究者
研究点 (1)
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