MedTrace Logo

Peripheral Blood ETASTs for Predicting Efficacy of Chemoimmunotherapy in NSCLC

NCT07392073 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-02-06

No results posted yet for this study

Summary

The goal of this observational study is to explore whether changes in peripheral blood effector tumor antigen-specific T cells (ETASTs) can predict treatment outcomes in patients with advanced non-small cell lung cancer (NSCLC) receiving chemoimmunotherapy. The study aims to:

* Evaluate the relationship between ΔETAST levels (baseline to cycle 2) and progression-free survival
* Compare the predictive performance of ΔETASTs with traditional biomarkers (PD-L1, TMB)
* Assess whether ΔETASTs can identify patients more likely to benefit from PD-1 inhibitor plus chemotherapy

Participants will:

* Provide peripheral blood samples at baseline and after cycle 2 of treatment
* Undergo ETAST quantification using the CTT-NanoDT technology with TATAN nanoparticles
* Have standard tumor assessments every 2 cycles according to RECIST 1.1 criteria
* Be followed for progression-free survival and overall survival up to 24 months

Conditions

Interventions

DIAGNOSTIC_TEST

Circulating Tumor-Specific T Cell Nanodetection Technology (CTT-NanoDT)

Novel detection method for quantifying effector tumor antigen-specific T cells (ETASTs) in peripheral blood. PBMCs isolated from 5 mL peripheral blood are co-incubated with TATAN nanoparticles (whole tumor cell antigen-loaded nanoparticles, 50 μg/mL) for 48 hours. Activated ETASTs are identified and quantified by multi-color flow cytometry as CD3+CD8+IFN-γ+ and CD3+CD8+CD137+ double-positive cells. Quality control requires coefficient of variation (CV) \< 5%.

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-04-30
Completion
2029-06-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07392073 on ClinicalTrials.gov