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
- 否
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
研究点 (1)
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