Blood microRNA markers to predict response to immunotherapy plus chemotherapy in extensive-stage small cell lung cancer
Small Extracellular Vesicle miRNAs as Predictive Biomarkers for Immunochemotherapy Efficacy in Extensive-stage Small Cell Lung Cancer
This project will test whether small extracellular vesicle microRNAs in blood can predict which patients with extensive-stage small cell lung cancer will respond to first-line immunotherapy combined with chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 38 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Chest Hospital of Shanghai Jiao Tong University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07070011 on ClinicalTrials.gov |
What this trial studies
A prospective observational cohort at Shanghai Chest Hospital will enroll treatment-naïve patients with extensive-stage small cell lung cancer who are starting first-line immunochemotherapy (EP/EC plus immune checkpoint inhibitors). Pretreatment serum will be collected and small extracellular vesicle microRNAs (sEV miRNAs) will be sequenced and compared between patients who respond and those who do not. Differential expression analysis will be used to identify miRNA signatures associated with treatment response. Identified signatures could serve as noninvasive liquid biopsy biomarkers to help personalize treatment decisions in ES-SCLC.
Who should consider this trial
Good fit: Ideal candidates are treatment-naïve adults with extensive-stage small cell lung cancer, ECOG 0–1, who are about to start first-line immunotherapy plus chemotherapy and can provide blood samples and clinical follow-up.
Not a fit: Patients with prior chemotherapy or immunotherapy, ECOG >1, incomplete clinical/sample data, or those unable to attend Shanghai Chest Hospital may not benefit from participation or from the biomarker findings.
Why it matters
Potential benefit: If successful, the biomarkers could help doctors predict who is likely to benefit from immunochemotherapy and avoid ineffective treatments.
How similar studies have performed: Similar liquid-biopsy miRNA approaches have shown promising preliminary results in other cancers and small lung-cancer cohorts, but no sEV-miRNA predictors for immunochemotherapy in ES-SCLC are yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Shanghai
- Shanghai Chest Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Wei Zhang, MD
- Email: zhwei2002@sjtu.edu.cn
- Phone: +86-021-62821990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.