NCT02044328已完成2 期
Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation: a Prospective, Exploratory Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The primary endpoint is disease-free survival.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients present with operable stage IIA-IIIA (N0-1) lung adenocarcinoma with 19 or 21 exon mutation
- •The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy
- •The patients' Eastern Cooperative Oncology Group scores are ≤ 0-1
- •The patients signed the written informed consent
排除标准
- •Patients with unresected tumor
- •Wild EGFR type
- •Allergic to the study drug
- •Patients have severe non-cancerous diseases
- •Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials
研究组 & 干预措施
Icotinib
Experimental
Patients receive icotinib 125 mg three times daily as adjuvant chemotherapy with for 18 months after surgery.
干预措施: Icotinib (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 2 years
次要结局
- 1-year Survival Rates(1 year)
- 3-year Survival Rates(3 years)
- Number of patients suffered adverse events(42 months)
研究者
研究点 (1)
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