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临床试验/NCT04263688
NCT04263688Unknown不适用

Multicenter Observational Study for Correlation Between Tumor Mutation Burden and Immunotherapy Efficacy of Advanced Non-small Cell Lung Cancer With Malignant Pleural Effusion

Guangzhou Institute of Respiratory Disease0 个研究点目标入组 300 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
主要终点
Progression-free survival (PFS) of NSCLC patients with malignant pleural effusion who were received immunotherapy

研究概览

简要总结

Multicenter observational study for correlation between tumor mutation burden and immunotherapy efficacy of advanced non-small cell lung cancer with malignant pleural effusion

详细描述

Method of Research:

  1. ⅢB-Ⅳ NSCLC patients, tumor mutation burden (TMB) was tested by the 448 gene panel with pleural effusion and tissue sample, to observed mutation characteristics;Tissue and pleural effusion cell precipitation:TMB (Next generation sequencing, 448 gene panel;Average sequencing depth: above 5000×)
  2. The date of blood routine examination(neutrophils to lymphocytes ratio (NLR)) and serological tumor maker of NSCLC were collected before treatment;the The results of Programmed death ligand 1 (PDL1) expression level were collected also;
  3. Collected Imaging(CT)and pathological data before treatment;
  4. Immunotherapy was applied for 8 weeks to evaluate the efficacy;
  5. The tumor mutation burden of pleural effusion was tested again for the patients of hyper-progression after immunotherapy, the mutation characteristics and changes were observed, the molecular mutation change before and after treatment were evaluated, and the correlation with immunotherapy was analyzed.Hyper-progression (HPD) were defined as tumor growth rate excess of 50% compared to baseline CT scans prior to treatment initiation.The patient underwent imaging examination (chest CT or pet-ct) at 2 months (8 weeks) after 3 full doses of immunotherapy drugs.
  6. The date of blood routine examination(neutrophils to lymphocytes ratio (NLR)) and serological tumor maker of NSCLC were collected after treatment;
  7. Imaging, CT and pathological data of patients after treatment were collected

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

入选标准

  • male or female,18 years ≤ age ≤80 years;
  • Pathologically confirmed stage ⅢB-Ⅳ NSCLC, which is not suitable for surgical resection;
  • No systematic anti-tumor treatment;
  • Pleural effusion ≥50ml,tissue samples can be obtained;
  • The driver gene was negative, and immunotherapy was proposed;
  • According to RECIST 1.1, at least one tumor lesion that can be measured or evaluated;
  • Signed and dated informed consent

排除标准

  • No pathological diagnosis or the diagnosis is not clear;
  • Severe pneumonia or tuberculosis;
  • Tumor tissues cannot be obtained;
  • Combine with other tumor type or other subtypes of lung cancer;
  • Poor compliance, unable to complete follow-up;
  • The investigator judges the situation that may affect the clinical search process and results

结局指标

主要结局

Progression-free survival (PFS) of NSCLC patients with malignant pleural effusion who were received immunotherapy

时间窗: 2021

The relationship between tumor mutation burden and progression-free survival in NSCLC patients

Objective response rate (ORR) of NSCLC patients with malignant pleural effusion who were received immunotherapy

时间窗: 2021

The relationship between tumor mutation burden and objective response rate in NSCLC patients

Overall survival (OS) of NSCLC patients with malignant pleural effusion who were received immunotherapy

时间窗: 2022

The relationship between tumor mutation burden and overall survival in NSCLC patients

次要结局

未报告次要终点

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

Chief Physician

Guangzhou Institute of Respiratory Disease

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