Shanghai Chest Hospital of Shanghai Jiao Tong University
Phase
Observational
Started
2023-01-03
Last updated
2025-07-17
Condition(s) studied
Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Investigational drug(s) / intervention(s)
EC/EP + ICIs
EC/EP + ICIs: Collect blood samples from patients with small cell lung cancer before receiving immunotherapy combined with chemotherapy.
Study 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.
Eligibility
Sex
ALL
Min age
45 Years
Max age
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;
Primary outcome measure(s)
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) .
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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