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临床试验/NCT03647592
NCT03647592招募中不适用

Real World Study to Evaluate the Efficacy and Resistant Mechanism of Erlotinib/Gefitinib Combined With Bevacizumab in First Line EGFR Mutation Positive Advanced Non-aquamous Non-small Cell Lung Cancer

Hunan Province Tumor Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
PFS

研究概览

简要总结

This study aims to explore the efficacy and safety of Erlotinib/Gefitinib combined with bevacizumab in the real world for advanced non-squamous cell lung cancer with EGFR mutation, explore new drug resistance mechanisms under the A+T regimen and consistency between plasma and tissue detection driving genes, and finally assess the predictive value of plasma dynamic detection driving gene mutation profiles in predicting disease. The role of disease progression risk.

详细描述

A retrospective study of 30 cases of advanced non-squamous non-small cell lung cancer (NSCLC) with EGFR mutation positive treated with A+T was conducted to observe the efficacy and safety of A+T regimen in the real world. Exploratory research contents are as follows: 1. Consistency between tissue gene test (NGS) and plasma gene test (NGS) at the initial diagnosis; 2. Consistency between tissue gene test (NGS) and plasma gene test (NGS) at the progression of A + T treatment; 3. New drug resistance mechanism of A + T treatment; 4. Plasma dynamics during A + T treatment. Detection (the first efficacy evaluation and a blood sampling before imaging PD) exploration and imaging progress sequence; 5. Plasma large panel dynamic drive gene mutation spectrum analysis to build disease progression risk model.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • EGFR mutation(19del/L858R)
  • advanced non-saquamous non-small cell lung cancer
  • primary treatment of first diagnosis
  • performance status(0-1)

排除标准

  • other genes mutation
  • saquamous

研究组 & 干预措施

Cohorts 1

patients with EGFR mutation-positive who received treatment of Erlotinib/Gefitinib Combined With Bevacizumab

干预措施: Erlotinib/Gefitinib combined with Bevacizumab (Drug)

结局指标

主要结局

PFS

时间窗: Approximately 1 years

Progression free survival

次要结局

  • OS(Approximately 1 years)
  • DCR(Approximately 1 years)

研究者

发起方
Hunan Province Tumor Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yongchang Zhang

professor

Hunan Province Tumor Hospital

研究点 (1)

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