An Open, Single Center Trial to Evaluate the Efficacy and Safety of Dose Escalation of Icotinib in Advanced NSCLC Patients After TKI Therapy
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
- safety and efficacy
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of dose escalation of Icotinib in advanced non small cell lung cancer (NSCLC) patients after the therapy of Icotinib, Iressa and Tarceva.
详细描述
- 1:to evaluate the efficacy correlation between the tyrosine kinase inhibitor (TKI) drugs and high-dose Icotonib group in advanced NSCLC patients with high -dose Icotinib going on after the routine TKI therapy
- 2 to evaluate the efficacy correlation between different high-dose group in advanced NSCLC patients with high -dose Icotinib going on after the routine TKI therapy
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
- •NSCLC patients were confirmed by histology or cytology
- •The time interval must be over 4 weeks from previous chemotherapy to registration to participate in this experiment if he or she received chemotherapy,and also have any toxicity to recover.
- •at least one measureable lesion accord to RECIST 1.1 criteria and the lesion accepted no radiotherapy.
- •1 at least one measureable lesion .if only one measureable lesion, the biological nature must be confirmed by cytology or histology.
- •2 a single diameter of lesion could be measured by at least one of the following methods: Chest or abdominal computed tomography(CT)or magnetic resonance imaging(MRI),conventional methods of diameter at least 20mm diameter spiral CT OR at least 10mm.
- •ECOG 0-2 score
- •at least 12 weeks of expected survival time
- •Women of childbearing age must have a pregnancy test 7 days before treatment and the result were negative ,men of childbearing age: surgical sterilization or treatment during and after the end of three months to take contraceptive measures
- •understand and sign a written informed consent voluntarily.
排除标准
- •If the subject meet any of the following exclusion criteria ,he is no eligible to participate in this study,
- •Before enrollment in this trial have used Erbitux, Herceptin and carried out anti-cancer therapy.
- •use of phenytoin, carbamazepine, rifampicin, phenobarbital or St. John's Wort when take this trial
- •severe allergies to Icotinib
研究组 & 干预措施
Icotinib
Patients can accept the treatment with Icotinib (250/375/500mg tid) until disease progression or unacceptable toxicity occurred. The overall study period takes about 24 months
干预措施: Icotinib (Drug)
结局指标
主要结局
safety and efficacy
时间窗: 2 years
1. The efficacy of dose escalation of Icotinib in advanced NSCLC patients after failure of TKI (Icotinib 125mg po tid. Iressa 250mg po qd. Tarceva 150mg po qd) therapy will be evaluated according to the revised RECIST 1.1 (Response Evaluation Criteria In Solid Tumors). 2. The safety of high dosage of Icotinib will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
次要结局
未报告次要终点
研究者
Pan Yueyin
Professor
Anhui Medical University