The Oncogenic Mutation Detection of Advanced NSCLC Patients by cSMART Liquid Biopsy and Dynamic Monitor of Tyrosine Kinase Inhibitor(TKI) Efficiency in Inner-Mongolia China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 129
- 试验地点
- 9
- 主要终点
- The TKI resistance gene mutation pattern in plasma DNA of TKI treated patient
研究概览
简要总结
The purpose of this study is to evaluate the mutation pattern of epidermal growth factor receptor (EGFR) and other TKI targeted gene during TKI treatment of advanced NSCLC patient with liquid biopsy.
详细描述
In the study, 200 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and Circulating Single-Molecule Amplification and Resequencing Technology (cSMART) liquid biopsy. those patients who carry EGFR activating mutation and other TKI targeted activating mutation will receive TKI treatment. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. the study will be ended when all the patients had a progressive disease (PD) in their targeted lesion
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •NSCLC adenocarcinoma patients confirmed by pathologist
- •Initial, non-operative patients with stage III & IV adenocarcinoma
- •Older than 18 years old
- •Subjects have no major organ dysfunction. In detail, Liver Function: TBiL≤1.5 ULN ( Upper Limit of Normal); Serum GPT (Glutamate-Pyruvate Transaminase ):≤2 ULN, Renal Function: ScR≤1.2 ULN; BUN≤1.2 ULN, BM (Bone Marrow) Reserve: WBC (White Blood cell Count) ≥4.0×e9/L; ANC≥2.0×e9/L，PLT≥100×e9/L，HGB≥100g/L.
- •PS (Performance Status) Score: less than 2, Expected Survival Time: More than 3 months;
- •Have a clear measurable tumor lesion in lung,under RIEST.
- •Without severe drug allergy
- •Patients participate in this trail must sign the informed consent
排除标准
- •Patients with brain metases related syndrome
- •Patients with bone metases related complication
- •Patients with cognitive disorder
- •Patients with major organ dysfunction and severe cardiopathy include congestive heart-failure, uncontrolled arrhythmia, angina with long term treatment, VHD (Valvular Heart Disease), myocardial infraction, RHTN (Resistant Hypertension).
- •Patients with other severe complication and excluded by the researcher.
- •Patients who are allergy with the TKI in this trail.
- •Patients who participated in other trails or with anti-tumor treatments
- •Patients who receive radiotherapy at the site of curative effect observation
- •Patients who receive allogenic blood transfusion within 14 days
结局指标
主要结局
The TKI resistance gene mutation pattern in plasma DNA of TKI treated patient
时间窗: 1.5 years
The researcher would like to find out the change of mutation in plasma DNA of the patients who received TKI treatment by a liquid biopsy method.
次要结局
- The concordance of gene mutation pattern between liquid biopsy and traditional cancer tissue biopsy(1 year)