Actively Recruiting

Age: 45Years - 80Years
All Genders
NCT07070011

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

Led by Shanghai Chest Hospital of Shanghai Jiao Tong University · Updated on 2025-07-17

38

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 45Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathological diagnosis of extensive-stage small cell lung cancer (ES-SCLC)
  • ECOG performance status score of 0 or 1
  • No prior chemotherapy treatment; receiving immunotherapy combined with chemotherapy for the first time
  • Complete clinical sample and follow-up information available
Not Eligible

You will not qualify if you...

  • Pathological diagnosis not consistent with ES-SCLC
  • ECOG performance status score not 0 or 1
  • History of chemotherapy, immunotherapy, or combined immunochemotherapy treatment
  • Incomplete clinical sample or follow-up information

AI-Screening

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Trial Site Locations

Total: 1 location

1

Shanghai Chest Hospital

Shanghai, China, 200030

Actively Recruiting

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Research Team

W

Wei Zhang, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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