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临床试验/NCT05310305
NCT05310305Unknown不适用

Combination of Immune Checkpoint Inhibitors PD-1 Monoclonal Antibody and Radiotherapy for Recurrent, Metastatic and Persistent Advanced Cervical Cancer: A Retrospective Cohort Study

Lei Li1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年3月26日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Objective remission rate

研究概览

简要总结

This study is to investigate retrospectively the effects of combination of immune checkpoint inhibitors anti-programmed death-1 antibody (PD-1 antibody) and radiotherapy for recurrent, metastatic and persistent advanced cervical carcinomas. Patients may or may not accept PD-1 antibody as maintenance therapy. Patients are followed up and the survival outcomes are evaluated. The primary endpoint are objective remission rate. The secondary endpoints are progression-free survival, overall survival and severe adverse events.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged 18 years or older
  • Confirmed of recurrent, metastatic, and persistent advanced cervical cancer
  • Confirmed of subtypes of cervical squamous carcinoma, adenocarcinoma and adenosquamous carcinoma
  • Accepting radiotherapy with concurrent anti PD-1 therapy
  • With detailed follow-up outcomes

排除标准

  • Not meeting all of the inclusion criteria

结局指标

主要结局

Objective remission rate

时间窗: One year

Objective remission rate in one month after the end of radiotherapy

次要结局

  • Progression-free survival(One year)
  • Overall survival(One year)
  • Severe adverse events(Two years)

研究者

发起方
Lei Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lei Li

Professor

Peking Union Medical College Hospital

研究点 (1)

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