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

NCT ID: NCT07070011

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-03
• Study Completion Date: 2026-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD).

Partial Response (PR): Defined as a reduction in the sum of the diameters of target lesions by ≥30% from baseline, in the absence of new lesions. This indicates effective treatment with significant tumor shrinkage.

Stable Disease (SD): Defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (i.e., the sum of the diameters of target lesions shows a change ranging from a decrease of <30% to an increase of <20%), in the absence of new lesions. This indicates that the disease has not worsened, but a significant reduction in tumor burden has not been achieved.

Progressive Disease (PD): Defined as an increase in the sum of the diameters of target lesions by ≥20% (taking as reference the smallest sum on study), and/or the appearance of one or more new lesions. This signifies treatment failure, necessitating a modification of the therapeutic regimen.

EC/EP + ICIs

Intervention Type: COMBINATION_PRODUCT

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

Interventions

EC/EP + ICIs

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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;

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital of Shanghai Jiao Tong University

OTHER

Sponsor Role: lead

Responsible Party

Wei Zhang

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Chest Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Zhang, MD

Role: CONTACT

zhwei2002@sjtu.edu.cn

+86-021-62821990

Facility Contacts

Wei Zhang, MD

Role: primary

zhwei2002@sjtu.edu.cn

+86-021-62821990

Other Identifiers

IS2109-(LGZ)

Identifier Type: -

Identifier Source: org_study_id