A Single Arm, Open Label, Perspective Study to Determine the Efficacy and Safety of Icotinib Combine Cryotherapy for Advanced NSCLC Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- progression-free survival
研究概览
简要总结
This trial is to designed to assess the efficacy and safety of Cryotherapy combine with Icotinib for Advanced NSCLC Patients harboring EGFR mutation.
详细描述
In this single arm clinical study, enrolled patients, with advanced stage NSCLC and confirmed epidermal growth factor receptor (EGFR) mutation, would receive cryotherapy for tumors and begin Icotinib, an EGFR tyrosine kinase inhibitor administration thereafter. Progression free survival, overall survival and safety wil be observed.
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
- •Histological or cytological confirmation of non-small cell lung cancer (NSCLC) in phase 3B/4;
- •Life expectancy ≥12weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •The number of target lesions in whole body ≤ 8 (and the number of lung lesions ≤ 5, the biggest one's diameter≤ 7 cm, the number of liver lesions ≤ three the biggest one's diameter ≤ 5 cm.
- •Adequate hematological function: hemoglobin ≥90g/L (no blood transfusion in 14 days) Absolute neutrophil count (ANC) ≥1.5 * 109/L, and Platelet count ≥75 x 10^9/L.
- •Adequate renal function: Serum creatinine ≤1.5 * upper limit of normal(ULN), or Serum creatinine≥ 50 ml/min. Adequate liver function: Total bilirubin ≤ 2 *ULN and Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)< 2.5 * ULN in the absence of liver metastases, or < 5 * ULN in case of liver metastases.
- •Female subjects should not be pregnant. All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications Written informed consent provided.
排除标准
- •Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
- •Allergic to Icotinib.
- •Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
- •Pregnancy or breast-feeding women.
- •Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction with in 6 months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
研究组 & 干预措施
Experimental
The subject receive Cryotherapy and than receive Icotinib 125mg, 3 times a day, orally administered until disease progression or intolerable toxicity reaction.
干预措施: Cryotherapy (Procedure)
Experimental
The subject receive Cryotherapy and than receive Icotinib 125mg, 3 times a day, orally administered until disease progression or intolerable toxicity reaction.
干预措施: Icotinib (Drug)
结局指标
主要结局
progression-free survival
时间窗: 2.5 years
the time that subjects reach their disease progress
次要结局
- overall survival(3-3.5 years)