NCT04906993进行中（未招募）3 期
A Randomized, Open-Label, Controlled, Multi-Center Phase III Clinical Study of Camrelizumab Combined With Famitinib Malate Versus Platinum-based Chemotherapy in the Treatment of Recurrent/Metastatic Cervical Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 443
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) assessed by the BIRC based on RECIST V1.1 criteria
研究概览
简要总结
This study is a randomized, open-label, controlled, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate versus platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer. All enrolled patients will be randomly divided into 2 groups and continuously treated until any event that meets the criteria for end of the clinical trial.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 18-75 years (including 18 and 75 years, calculated based on the signing date of the informed consent)
- •Histopathologically confirmed recurrent/metastatic cervical squamous cell carcinoma that cannot be radically treated by surgery, radiotherapy or chemoradiotherapy
- •No prior systemic anti-cancer therapy for recurrent/metastatic disease
- •According to RECIST v1.1 criteria, the patient must have at least one measurable lesion
- •Able to normally swallow drug tablets
- •The organ function level is good
- •Willing to participate and able to comply with research programme requirements
排除标准
- •Has any malignancy <5 years prior to study entry.
- •Known to have brain or meningeal metastasis
- •Known to have autoimmune disease
- •Received live vaccinations 4 weeks before randomization or during the study period
研究组 & 干预措施
camrelizumab combined with famitinib malate
Experimental
干预措施: camrelizumab； famitinib malate (Drug)
platinum-based chemotherapy
Active Comparator
干预措施: platinum-based chemotherapy (Drug)
结局指标
主要结局
Progression-free survival (PFS) assessed by the BIRC based on RECIST V1.1 criteria
时间窗: up to 2 years
Overall survival (OS)
时间窗: up to 3 years
次要结局
- Duration of response (DOR) assessed based on RECIST V1.1 criteria(up to 2 years)
- Time to response (TTR) assessed based on RECIST V1.1 criteria(up to 2 years)
- Progression-free survival (PFS) in subjects in the control group who receive camrelizumab after progression(up to 2 years)
- Progression-free survival (PFS) assessed by the investigator based on RECIST V1.1 criteria(up to 2 years)
- Objective response rate (ORR) assessed based on RECIST V1.1 criteria(up to 2 years)
- Disease control rate (DCR) assessed based on RECIST V1.1 criteria(up to 2 years)
- Time to treatment failure (TTF)(up to 2 years)
研究者
研究点 (1)
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