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NCT07392073

Peripheral Blood ETASTs for Predicting Efficacy of Chemoimmunotherapy in NSCLC

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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

Official title: Prospective Study of Changes in Peripheral Blood Effector Tumor Antigen-Specific T Cells for Predicting Efficacy of Chemoimmunotherapy in Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2026-04

Completion Date

2029-06

Last Updated

2026-02-06

Healthy Volunteers

Conditions

Non-Small Cell Lung Cancer Lung Adenocarcinoma Lung Squamous Cell Carcinoma Stage IIIB Non-Small Cell Lung Cancer Stage IV Non-Small Cell Lung Cancer Advanced Non-Small Cell Lung Cancer

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%.

Inclusion Criteria: * Histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC) * Planned to receive PD-1 inhibitor combined with platinum-based chemotherapy (e.g., pembrolizumab + pemetrexed/carboplatin) * Age 18-80 years * ECOG performance status 0-1 * Expected survival ≥12 weeks * Adequate bone marrow function: ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L * Adequate hepatorenal function: Cr ≤1.5×ULN, ALT/AST ≤2.5×ULN * At least one measurable lesion per RECIST 1.1 criteria * Able to provide informed consent and comply with study procedures including serial blood sampling and imaging follow-up Exclusion Criteria: * No measurable disease per RECIST 1.1 criteria * Tumor emergencies requiring immediate intervention (spinal cord compression, superior vena cava syndrome) * Active untreated central nervous system metastases or leptomeningeal disease * Prior treatment with immune checkpoint inhibitors within 4 weeks before enrollment * Chronic use of immunosuppressive agents (e.g., corticosteroids \>10 mg/day prednisone equivalent) * Coagulation disorders (INR \>1.5 or APTT \>1.5×ULN) or ongoing anticoagulation therapy * Poor vascular access precluding serial venipuncture (\>5 mL per draw) * Active hepatitis B (HBV DNA \>2000 IU/mL), hepatitis C, or HIV infection * Uncontrolled bacterial or fungal infection requiring systemic treatment * Pregnancy or lactation * Severe psychiatric disorder or communication barriers affecting informed consent or follow-up compliance Withdrawal Criteria: * Participant voluntary withdrawal with signed withdrawal statement * Major protocol violations: failure to receive ≥2 cycles of planned chemoimmunotherapy; missing ≥2 critical timepoint blood samples (baseline, cycle 2) * Uncontrollable grade ≥3 immune-related adverse events requiring permanent discontinuation of PD-1 inhibitor Study Termination Criteria: * Disease progression confirmed by imaging per RECIST 1.1 or clinical progression requiring radiotherapy * Death or loss to follow-up \>6 months * Unacceptable grade 4 treatment-related toxicity * Investigator determination that continued participation poses health risk to patient * Study terminated by ethics committee for scientific or administrative reasons