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临床试验/NCT03008109
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

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

发起方
Zaiwen Fan
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Zaiwen Fan

Director of oncology department

Air Force General Hospital of the PLA

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