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Clinical Trial NCT07070011 for Extensive-stage Small Cell Lung Cancer (ES-SCLC) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Small Extracellular Vesicle miRNAs as Predictive Biomarkers for Immunochemotherapy Efficacy in Extensive-stage Small Cell Lung Cancer 38 Biomarker-Driven Observational Novel Treatment Personalized Treatment

Recruiting
Clinical Trial NCT07070011 is an observational study for Extensive-stage Small Cell Lung Cancer (ES-SCLC) that is recruiting. It started on 3 January 2023 with plans to enroll 38 participants. Led by Shanghai Chest Hospital of Shanghai Jiao Tong University, it is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 17 July 2025.
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 individualize...Show More
Official Title

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

Conditions
Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Other Study IDs
  • IS2109-(LGZ)
NCT ID Number
NCT07070011
Start Date (Actual)
2023-01-03
Last Update Posted
2025-07-17
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
38
Study Type
Observational
Status
Recruiting
Keywords
small cell lung cancer
immunochemotherapy
sEV miRNAs
predictive biomarkers
Arms / Interventions
Participant Group/ArmIntervention/Treatment
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 r...Show More
EC/EP + ICIs
Collect blood samples from patients with small cell lung cancer before receiving immunotherapy combined with chemotherapy.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Tumor Response Status per RECIST 1.1
* Assessment Tool: RECIST 1.1 criteria ; * Unit of Measure: Number of patients (n) and percentage (%) ; * Data Aggregation Method: Calculation of proportions of patients in each response category (PR/SD/PD); Definitions: * Partial Response (PR): ≥30% reduction in the sum of diameters of target lesions from baseline (absence of new lesions) ; * Stable Disease (SD): Change in the sum of diameters ranging from \<30% reduction to \<20% increase (absence of new lesions) ; * Progressive Disease (PD): ≥20% increase in the sum of diameters (reference: smallest sum recorded) and/or appearance of new lesions ;
6 to 8 weeks
Baseline Serum sEV miRNA Expression Levels
* Measurement Tool: Next-generation sequencing (NGS) ; * Unit of Measure: Standardized expression values (CPM, Counts Per Million) ; * Data Aggregation Method: Descriptive statistics (mean ± SD or median \[IQR\]) of expression levels by response groups ; * Procedure: 1. Pre-treatment serum collection ; 2. sEV isolation ; 3. miRNA extraction ; 4. NGS sequencing ; 5. Bioinformatic normalization (CPM) .
Baseline (pre-treatment)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
45 Years
Eligible Sexes
All

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

  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;
Shanghai Chest Hospital of Shanghai Jiao Tong University logoShanghai Chest Hospital of Shanghai Jiao Tong University
Study Responsible Party
Wei Zhang, Principal Investigator, Chief Physician, Shanghai Chest Hospital of Shanghai Jiao Tong University
Study Central Contact
Contact: Wei Zhang, MD, +86-021-62821990, [email protected]
1 Study Locations in 1 Countries
Shanghai Chest Hospital, Shanghai, 200030, China
Wei Zhang, MD, Contact, +86-021-62821990, [email protected]
Recruiting