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

Shanghai Chest Hospital of Shanghai Jiao Tong University38 enrolled

Overview

This study aims to investigate the clinical value of small extracellular vesicle (sEV) miRNAs as predictive biomarkers for immunochemotherapy efficacy in extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC represents a highly aggressive neuroendocrine malignancy, where the current standard first-line treatment combining immune checkpoint inhibitors with chemotherapy lacks predictive biomarkers for individualized therapeutic strategies. A prospective observational cohort will be established at Shanghai Chest Hospital, enrolling treatment-naïve ES-SCLC patients. Distinct miRNA signatures differentiating responders from non-responders will be identified through pretreatment serum sEV miRNA sequencing and differential expression analysis. These findings may provide novel liquid biopsy biomarkers to guide personalized treatment strategies and optimize clinical decision-making in ES-SCLC management.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Interventions

EC/EP + ICIsCOMBINATION_PRODUCT

Collect blood samples from patients with small cell lung cancer before receiving immunotherapy combined with chemotherapy.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: Requirements for patients enrolled in the project: 1. The pathological diagnosis of the patient is ESSCLC; 2. ECOG score 0 or 1； 3. The patient is receiving immunotherapy combined with chemotherapy for the first time and has no history of chemotherapy treatment; 4. Patients with complete clinical sample information who meet the inclusion requirements Exclusion Criteria: 1. Patients whose pathological diagnosis does not meet the requirements; 2. Patients whose ECOG staging does not meet the requirements; 3. Patients with a history of chemotherapy, immunotherapy, or immunotherapy combined with chemotherapy; 4. Patients with incomplete clinical sample information and follow-up information;

Outcomes

Primary Outcomes

Tumor Response Status per RECIST 1.1

* 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 ;

Time frame: 6 to 8 weeks

Baseline Serum sEV miRNA Expression Levels

* Measurement Tool: Next-generation sequencing (NGS) ; * Unit of Measure: Standardized expression values (CPM, Counts Per Million) ; * Data Aggregation Method: Descriptive statistics (mean ± SD or median \[IQR\]) of expression levels by response groups ; * Procedure: 1. Pre-treatment serum collection ; 2. sEV isolation ; 3. miRNA extraction ; 4. NGS sequencing ; 5. Bioinformatic normalization (CPM) .

Time frame: Baseline (pre-treatment)