NCT03008109Unknown3 期
Short-term Injection of Recombinant Human Endostatin Plus EGFR-TKI as a Treatment of EGFR Mutation-positive Advanced Non-small Cell Lung Cancer
Zaiwen Fan0 个研究点目标入组 80 人开始时间: 2017年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 主要终点
- progression-free survival
研究概览
简要总结
EGFR Tyrosine-Kinase Inhibitor monotherapy is widely used in treatment of patients with EGFR mutation-positive Non-small cell lung cancer(NSCLC), In despite of the benefit of PFS (progression-free survival) , the OS ( overall survival) is limited extended. This study is aim to observe the safety and efficacy of the combination of an anti-angiogenic drug recombinant human-endostatin with EGFR TKI ,to find out a new strategy which may further extend the PFS and OS with a tolerated toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Advanced NSCLC,EGFR mutation positive,PS(performance status) 0-2,Patients were required to have one or more measurable lesions
排除标准
- 未提供
研究组 & 干预措施
EGFR-TK inhibitor plus RH-endostatin
Experimental
EGFR-TKI icotinib:125mg Tid RH-endostatin:15mg/m2 ,d1-7
干预措施: EGFR-TK Inhibitor (Drug)
结局指标
主要结局
progression-free survival
时间窗: 18 month
次要结局
未报告次要终点
研究者
Zaiwen Fan
Director of oncology department
Air Force General Hospital of the PLA
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