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

Shanghai Chest Hospital of Shanghai Jiao Tong University

Status: Enrolling

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

Treatments: Combination Product: EC/EP + ICIs

Study type: Observational

Funder types: Other

Identifiers

NCT07070011

IS2109-(LGZ)

Details and patient eligibility

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

38 participants in 1 patient group

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

Description:

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.

Treatment:

Combination Product: EC/EP + ICIs