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RECRUITING
NCT07070011

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

Sponsor: Shanghai Chest Hospital of Shanghai Jiao Tong University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

45 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

38

Start Date

2023-01-03

Completion Date

2026-12-31

Last Updated

2025-07-17

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

EC/EP + ICIs

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

Locations (1)

Shanghai Chest Hospital

Shanghai, China