NCT03402464Unknown2 期
Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced Gradually Progressed NSCLC After First-line Icotinib: an Open-label, Single-arm, Multicenter Phase II Study
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progress Free Survival
研究概览
简要总结
The study was to evaluate the safety, PFS and ORR of icotinib/dihydroaremisinin (DHA)-based combination therapy in EGFR-mutated, advanced NSCLC patients who have gradually progressed disease after first-line icotinib treatment.
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
- •Patients confirmed with stage IV lung adenocarcinoma by pathologic histology or cytology who can't accept surgery and radiotherapy
- •Male or female patients aged ≥18 years, life expectancy ≥ 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Sensitive EGFR gene mutation(19/21)
- •Failed with first-line icotinib and have gradually progressed disease More than 6-month duration of first-line icotinib (from the first dosing to the imaging-confirmed progression; and discontinuation of icotinib is less than 14 days) No significantly increased tumor size compared with the final imaging evaluation
排除标准
- •Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease)
- •Female subjects should not be pregnant or breast-feeding
- •Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
- •Previous systemic anti-tumor therapy except for icotinib , including chemotherapy or targeted therapy ( including but not limited to monoclonal or antibodies, small molecule tyrosine kinase inhibitor, etc)
- •Tumor metastasis of the spinal cord, meninges or meningeal neoplasms confirmed by imaging or cerebrospinal fluid examination
研究组 & 干预措施
Icotinib combined dihydroaremisinin
Experimental
干预措施: Icotinib combined dihydroaremisinin (Drug)
结局指标
主要结局
Progress Free Survival
时间窗: 18 months
Objective response rate
时间窗: 18 months
次要结局
- Overall Survival(24 months)
研究者
Ziping Wang
professor of medicine
Peking University Cancer Hospital & Institute
研究点 (1)
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