跳至主要内容
临床试验/NCT04805099
NCT04805099已完成不适用

Real-world Safety and Efficacy Data of Checkpoint Inhibitors in Patients With Cancer and Underlying Autoimmune Disease: the Experience of the Hellenic Cooperative Oncology Group

Hellenic Cooperative Oncology Group1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2020年11月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
126
试验地点
1
主要终点
progression-free survival

研究概览

简要总结

Patients with cancer and concurrent autoimmune diseases (AID) have been universally excluded from clinical trials evaluating immunotherapy. Data on the safety and efficacy of checkpoint inhibitors in patients with underlying AID is limited. The investigators performed a retrospective multicenter review of medical records of patients with diverse tumor types and underlying AID who received checkpoint inhibitors at Departments of Oncology, affiliated with the Hellenic Cooperative Oncology Group (HeCOG). The primary endpoint was progression-free survival (PFS).

研究设计

研究类型
Observational
观察模型
Case Only
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

  • 18 years or older
  • Patients with cancer
  • Patients with autoimmune disease
  • Treated at HeCOG-affiliated Departments of Oncology
  • Early-stage or metastatic

排除标准

  • diagnosis of the autoimmune disease after initiation of immunotherapy

结局指标

主要结局

progression-free survival

时间窗: Through the completion of the study, for an average of 6 months

次要结局

未报告次要终点

研究者

发起方
Hellenic Cooperative Oncology Group
申办方类型
Other
责任方
Sponsor

研究点 (1)

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