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临床试验/NCT04405661
NCT04405661Unknown不适用

Correlation Between Specific Gene Mutationand Local Immune Microenvironment and Immunotherapy Efficacy in NSCLC

Guangzhou Institute of Respiratory Disease1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年4月28日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Correlation between specific gene mutation and immune microenvironment

研究概览

简要总结

Immunotherapy for PD-L1 positive patients is still ineffective in some patients,which may be related to the complex immune microenvironment.In view of this bottleneck, further refinement of immunotyping and in-depth study of drug resistance mechanism are the most important tasks. In this observational study, we evaluated the difference of gene mutation and immune microenvironment and therapeutic effect in primary NSCLC.

详细描述

There are still some patients with PD-L1 positive who are ineffective in immunotherapy, which may be related to the complex immune microenvironment. In view of this bottleneck, further refinement of immunotyping and in-depth study of drug resistance mechanism are the most important tasks.

Recently, studies have shown that the core elements of tumor microenvironment that have a significant impact on immunotherapy are:1. Infiltration abundance of specific killer T cells; 2. PD-L1 expression dependent on IFN - γ pathway, down-regulation of various active molecules and up-regulation of inhibitory molecules; 3. Activation and clearance of various inhibitory T cells.

Although the classification has achieved further refinement of immune cells and molecular level, there are still some problems to be solved urgently: first, the classification of TIL cells needs further refinement, and different types of TIL infiltration have different guiding significance for prognosis; second, the subjective second-order semi quantitative scoring is often used for til count scoring, with low repeatability and different centers It is not easy for different pathologists to reach an agreement on the results of reading and interpretation. Thirdly, conventional methods are difficult to meet the requirements of tumor microenvironment analysis. In conclusion, it is urgent to develop a multi molecular marker landscape analysis system for tumor microenvironment, and establish a standardized detection process for each molecule to meet the needs of clinical positioning, quantitative and qualitative analysis for key molecular markers of immune microenvironment.

In this observational study, we evaluated the difference of gene mutation and immune microenvironment and therapeutic effect in primary NSCLC.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non small cell lung cancer was diagnosed by cytology or histopathology;
  • Patients to be treated with PD-1 / PD-L1 inhibitors;
  • Who signed the informed consent for participating in the research plan

排除标准

  • History of other malignancies
  • Cancer meningitis in subjects
  • Incomplete clinical follow-up data
  • Failure to sign informed consent to participate in the research program

结局指标

主要结局

Correlation between specific gene mutation and immune microenvironment

时间窗: up to 1year

Correlation between specific gene mutation and immune microenvironment

Correlation between specific gene mutations and ORR and PFS in immunotherapy patients with lung cancerof lung cancer patients with immunotherapy

时间窗: up to 1year

Correlation between specific gene mutations and ORR and PFS in immunotherapy patients with lung cancer

Correlation between immune microenvironment and ORR and PFS in immunotherapy lung cancer patients

时间窗: up to 1year

Correlation between immune microenvironment and ORR and PFS in immunotherapy lung cancer patients

次要结局

  • Correlation between immune microenvironment and OS in immunotherapy lung cancer patients(up to 1year)
  • Correlation of OS with specific gene mutation in immunotherapy of lung cancer(up to 1year)

研究者

发起方
Guangzhou Institute of Respiratory Disease
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhou Chengzhi

PHD,Chief Physician

Guangzhou Institute of Respiratory Disease

研究点 (1)

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