Non-Small Cell Lung Cancer Clinical Trial
Official title:
Multicenter Observational Study for Correlation Between Tumor Mutation Burden and Immunotherapy Efficacy of Advanced Non-small Cell Lung Cancer With Malignant Pleural Effusion
Multicenter observational study for correlation between tumor mutation burden and immunotherapy efficacy of advanced non-small cell lung cancer with malignant pleural effusion
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
;
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