Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Conditions
Keywords
small cell lung cancer, immunochemotherapy, sEV miRNAs, predictive biomarkers
Brief summary
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.
Interventions
COMBINATION_PRODUCTEC/EP + ICIs
Collect blood samples from patients with small cell lung cancer before receiving immunotherapy combined with chemotherapy.
Sponsors
Shanghai Chest Hospital of Shanghai Jiao Tong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response Status per RECIST 1.1 | 6 to 8 weeks | * 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 ; |
| Baseline Serum sEV miRNA Expression Levels | Baseline (pre-treatment) | * 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) . |
Countries
China
Contacts
Primary ContactWei Zhang, MD
Outcome results
None listed