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临床试验/NCT04956783
NCT04956783已完成不适用

Comparison of the Occurrence of Adverse Effects With Immune Checkpoint Inhibitors Between a Single and Double Dose Regimen

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
To compare the incidence of clinical significant toxicities

研究概览

简要总结

This is a retrospective evaluation of the impact of a double dose regimen of immunotherapy use in cancer treatment compared to the single-dose regimen on the occurrence of clinically significant adverse events.

The aim of this study is to provide evidence-based arguments to help clinicians to propose the best treatment regimen for each patient.

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
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To compare the incidence of clinical significant toxicities

时间窗: 18 months

To compare the incidence of clinical significant toxicities reported for patients treated with a cancer immunotherapy on a simple dose regiment versus double dose regimen

次要结局

  • To describe the management and evolution of toxicities(18 months)
  • To describe the clinical oncologic response(18 months)
  • To describe the incidence(18 months)
  • To identify risk factors for the development of severe toxicity(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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