NCT07070011

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 38 (estimated)
• Sponsor: Shanghai Chest Hospital of Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	EC/EP + ICIs	Collect blood samples from patients with small cell lung cancer before receiving immunotherapy combined with chemotherapy.

Timeline

• Start date: 2023-01-03
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-07-17
• Last updated: 2025-07-17

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study