ITMCTR1900002685尚未招募3 期
A randomized controlled, double-blind study of Chinese medicine combined with EGFR-TKI in the treatment of stage IV EGFR mutation-positive non-small cell lung cancer
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 80（—）
- 性别
- All
入选标准
- •(1) pathological or cytological diagnosis of stage IV lung cancer with tumor patients;
- •(2) EGFR gene mutations, including exon 19 deletion mutation (19DEL), exon 21 point mutation (21L858R), 18 exon G719X, 20 exon S768I and 21 exon L861Q mutation are also sensitive Sexual mutation, T790M mutation.
- •(3) Age = 18 years old;
- •(4) The estimated survival period is = 3 months;
- •(5) The subject has no major organ dysfunction. Blood routine, liver, kidney, and cardiac function are normal: hemoglobin = 120g / L, absolute neutrophil count (ANC) = 1.5 × 109 / L, platelet = 80 × 109 / L, bilirubin = 1.5ULN, alkaline phosphatase (AP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × ULN. INR = 1.5, creatinine = 1.5ULN.
排除标准
- •(1) Have a history of other tumors within 5 years;
- •(2) T790M mutation carrying 20 exons, intended to be treated with EGFR-TKI first-generation drugs;
- •(3) Those with an expected life expectancy of <3 months;
- •(4) symptomatic brain metastases;
- •(5) History of cardiovascular disease: congestive heart failure > level II in NYHA cardiac function. Patients with unstable angina (symptoms of angina at rest) or newly occurring angina (starting in the past 3 months) or myocardial infarction occurred in the past 6 months. Active infection, > Level 2 adverse events (CTC AE. Version 4.0);
- •(6) Pregnant or lactating patients;
- •(7) People with a history of mental illness that is difficult to control.
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