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Clinical Trial Summary

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


Clinical Trial Description

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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04263688
Study type Observational
Source Guangzhou Institute of Respiratory Disease
Contact Chengzhi Zhou
Phone 020-83062830
Email doctorzcz@163.com
Status Not yet recruiting
Phase
Start date March 1, 2020
Completion date March 1, 2022

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