NCT07472153招募中2 期
To Validate, Develop and Implement The Scope of Medical Care for Metastatic, Persistent and Recurrent Cervical Cancer Using The Method of Chemoimmunotargeted Therapy
N.N. Alexandrov National Cancer Centre1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年7月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This is a randomized trial evaluating the results of using of PD-1 and PD-L1 immune checkpoint inhibitors combined with chemotherapy, with or without bevacizumab, in patients with metastatic, persistent, and recurrent 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
- Single (Participant)
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
- •Age ≥18-≤75 years.
- •Histologically confirmed diagnosis.
- •One of the forms of the cervical cancer:
- •Metastatic cervical cancer (stage IVB according to FIGO (International Federation of Gynaecology and Obstetrics) 2018);
- •Persistent cervical cancer (primary incurability after radical treatment for stages IIB-IVA cervical cancer according to FIGO 2018);
- •Reccurent cervical cancer (first recurrence after completed radical treatment for IA-IVB cervical cancer according to FIGO 2018).
- •Availability of material for determining PD-L-1 expression for immunotherapy candidates.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •No contraindications to chemotherapy, immunotherapy, or bevacizumab.
- •Signed informed consent to participate in the study.
排除标准
- •Presence of another active malignant invasive neoplasm.
- •Pregnancy or lactation period.
研究组 & 干预措施
PD-1
Experimental
干预措施: PD-1 antibody (Drug)
PD-L1
Experimental
干预措施: PD-L1 antibody (Drug)
Standard
Active Comparator
干预措施: Chemotherapy and bevacizumab (CT-BEV) (Drug)
结局指标
主要结局
Overall survival
时间窗: From enrollment through study completion, an average of 2 year
Time from randomization to the death of any cause
Median overall survival
时间窗: From date of treatment initiation until the date of death from any cause, assessed up to 36 months
The timepoint at which 50% of patients are still alive following treatment initiation
次要结局
- Objective response rate(From randomization until progression or study completion, average of 60 months)
- Duration of response(From date of first documented response until progression or death, assessed up to 60 months)
- Disease-free survival(From enrollment through study completion, an average of 2 year)
- Median Disease-free survival(From date of treatment initiation until the date of death from any cause, assessed up to 36 months)
研究者
研究点 (1)
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