Actively Recruiting
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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the role of small extracellular vesicle (sEV) microRNAs (miRNAs) as predictive biomarkers for how well immunochemotherapy works in people with extensive-stage small cell lung cancer (ES-SCLC), a very aggressive type of lung cancer. Since current treatments combining immune checkpoint inhibitors with chemotherapy do not have markers to predict which patients will benefit, this study aims to find miRNA patterns that differentiate patients who respond to treatment from those who do not. This research is taking place at Shanghai Chest Hospital and focuses on treatment-nave patients with ES-SCLC. The study involves collecting blood samples before patients start immunotherapy combined with chemotherapy to analyze the miRNA in serum sEVs. The research team will sequence these miRNAs and compare differences between responders and non-responders. They will categorize tumor responses as partial response (significant tumor shrinkage), stable disease (no significant change in tumor size), or progressive disease (tumor growth or new lesions). This observational study tracks patients receiving the combination treatment of EC/EP chemotherapy plus immune checkpoint inhibitors. Participants will be monitored over time with assessments including tumor response status every 6 to 8 weeks and measurement of baseline serum sEV miRNA levels before treatment begins. The study collects complete clinical sample and follow-up information to identify biomarkers that may help guide personalized treatment decisions for ES-SCLC. The trial is expected to continue until the end of 2026 and includes adults aged 45 to 80 years who are starting immunochemotherapy for the first time.
CONDITIONS
Brief Title
Small Extracellular Vesicle miRNAs as Predictive Biomarkers for Immunochemotherapy Efficacy in Extensive-stage Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathological diagnosis of extensive-stage small cell lung cancer (ES-SCLC)
- ECOG performance status score of 0 or 1
- Receiving immunotherapy combined with chemotherapy for the first time with no prior chemotherapy treatment
- Complete clinical sample and follow-up information available
You will not qualify if you...
- Pathological diagnosis not meeting ES-SCLC requirements
- ECOG performance status score not 0 or 1
- History of chemotherapy, immunotherapy, or combined immunochemotherapy
- Incomplete clinical sample or follow-up information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline (pre-treatment)
Participants have blood samples collected before receiving immunotherapy combined with chemotherapy to evaluate biomarkers.
1 visit (in-person)
Duration - 6 to 8 weeks
Participants are observed for tumor response status to immunochemotherapy treatment.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, China, 200030
Actively Recruiting
Research Team
W
Wei Zhang, MD
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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