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A Controlled Clinical Study of Endostar/PD-1 Inhibitors Combined With chemotherapy(Carboplatin-Pemetrexed) as First-line Treatment for Advanced Non-squamous Cell Lung Cancer With Negative Driving Gene
Full description
This study was a controlled clinical trial.A total of 170 patients with pathologically confirmed non-squamous NSCLC would be enrolled.Patients were randomly divided into two groups, with 85 in the group A and 85 in the group B.The group A was treated with endostar,sintilimab and chemotherapy(carboplatin-pemetrexed).The group B was treated with endostar and chemotherapy(carboplatin-pemetrexed).The efficacy and safety would be evaluated.The progression-free survival and overall survival would be analyzed.This data of this study might provide a more effective treatment for non-squamous NSCLC.
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Inclusion criteria
(1)Blood routine examination ( without blood transfusion in 14 days): hemoglobin (HB) ≥ 90 g/L; neutrophil absolute value (ANC) ≥ 1.5 *109/L; platelet (PLT) ≥80 *109/L.
(2) Biochemical tests should meet the following criteria: 1) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); 2) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 *ULN, if accompanied by liver metastasis, ALT and AST ≤ 5* ULN; 3) serum creatinine (Cr) ≤ 1.5* ULN or creatinine clearance rate (CCr) ≥ 60 ml/min;4) Serum albumin (≥35g/L).
(3) Doppler echocardiography: left ventricular ejection fraction (LVEF) ≥the low limit of normal value (50%).
9 Tissue samples should be provided for biomarker analysis (such as PD-L1 ) Patients who could not provide new tissues could provide 5-8 paraffin sections of 3-5 μm by archival preservation.
Exclusion criteria
Primary purpose
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Interventional model
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170 participants in 2 patient groups
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Central trial contact
Dong Wang, PH.D
Data sourced from clinicaltrials.gov
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