Small Extracellular Vesicle miRNAs as Predictive Biomarkers for Immunochemotherapy Efficacy in Extensive-stage Small Cell Lung Cancer

Arms (1)

1. label

   Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD).

   description

   Partial Response (PR): Defined as a reduction in the sum of the diameters of target lesions by ≥30% from baseline, in the absence of new lesions. This indicates effective treatment with significant tumor shrinkage. Stable Disease (SD): Defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (i.e., the sum of the diameters of target lesions shows a change ranging from a decrease of \<30% to an increase of \<20%), in the absence of new lesions. This indicates that the disease has not worsened, but a significant reduction in tumor burden has not been achieved. Progressive Disease (PD): Defined as an increase in the sum of the diameters of target lesions by ≥20% (taking as reference the smallest sum on study), and/or the appearance of one or more new lesions. This signifies treatment failure, necessitating a modification of the therapeutic regimen.

   interventionNames

   1. Combination Product: EC/EP + ICIs

Primary outcomes (2)

1. measure

   Tumor Response Status per RECIST 1.1

   timeFrame

   6 to 8 weeks

   description

   * Assessment Tool: RECIST 1.1 criteria ; * Unit of Measure: Number of patients (n) and percentage (%) ; * Data Aggregation Method: Calculation of proportions of patients in each response category (PR/SD/PD); Definitions: * Partial Response (PR): ≥30% reduction in the sum of diameters of target lesions from baseline (absence of new lesions) ; * Stable Disease (SD): Change in the sum of diameters ranging from \<30% reduction to \<20% increase (absence of new lesions) ; * Progressive Disease (PD): ≥20% increase in the sum of diameters (reference: smallest sum recorded) and/or appearance of new lesions ;