[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623087":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":20,"collaborators":10,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":29,"acronym":10,"eligibilityCriteria":30,"healthyVolunteers":26,"sex":31,"minAge":32,"maxAge":33,"enrollmentInfo":34,"targetDuration":37,"studyType":38,"phases":10,"briefSummary":39,"conditions":40,"keywords":47,"overallStatus":53,"whyStopped":10,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":10},{"fullName":5,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NSCLC Patients Receiving Chemoimmunotherapy",null,"Patients with stage IIIB-IV non-small cell lung cancer receiving standard PD-1 inhibitor (such as pembrolizumab) combined with platinum-based chemotherapy (such as pemetrexed\u002Fcarboplatin or paclitaxel\u002Fcarboplatin regimen). Peripheral blood samples collected at baseline and after cycle 2 for ETAST quantification using CTT-NanoDT technology.",[13],"Diagnostic Test: Circulating Tumor-Specific T Cell Nanodetection Technology (CTT-NanoDT)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"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\u002FmL) 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) \\\u003C 5%.",[9],{"type":21,"investigatorFullName":22,"investigatorTitle":23,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Weibiao Zeng","Attending Physician","100623087","peripheral-blood-etasts-for-predicting-efficacy-of-chemoimmunotherapy-in-nsclc-100623087",false,"NCT07392073","Peripheral Blood ETASTs for Predicting Efficacy of Chemoimmunotherapy in NSCLC","Prospective Study of Changes in Peripheral Blood Effector Tumor Antigen-Specific T Cells for Predicting Efficacy of Chemoimmunotherapy in Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC)\n* Planned to receive PD-1 inhibitor combined with platinum-based chemotherapy (e.g., pembrolizumab + pemetrexed\u002Fcarboplatin)\n* Age 18-80 years\n* ECOG performance status 0-1\n* Expected survival ≥12 weeks\n* Adequate bone marrow function: ANC ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL\n* Adequate hepatorenal function: Cr ≤1.5×ULN, ALT\u002FAST ≤2.5×ULN\n* At least one measurable lesion per RECIST 1.1 criteria\n* Able to provide informed consent and comply with study procedures including serial blood sampling and imaging follow-up\n\nExclusion Criteria:\n\n* No measurable disease per RECIST 1.1 criteria\n* Tumor emergencies requiring immediate intervention (spinal cord compression, superior vena cava syndrome)\n* Active untreated central nervous system metastases or leptomeningeal disease\n* Prior treatment with immune checkpoint inhibitors within 4 weeks before enrollment\n* Chronic use of immunosuppressive agents (e.g., corticosteroids \\>10 mg\u002Fday prednisone equivalent)\n* Coagulation disorders (INR \\>1.5 or APTT \\>1.5×ULN) or ongoing anticoagulation therapy\n* Poor vascular access precluding serial venipuncture (\\>5 mL per draw)\n* Active hepatitis B (HBV DNA \\>2000 IU\u002FmL), hepatitis C, or HIV infection\n* Uncontrolled bacterial or fungal infection requiring systemic treatment\n* Pregnancy or lactation\n* Severe psychiatric disorder or communication barriers affecting informed consent or follow-up compliance\n\nWithdrawal Criteria:\n\n* Participant voluntary withdrawal with signed withdrawal statement\n* Major protocol violations: failure to receive ≥2 cycles of planned chemoimmunotherapy; missing ≥2 critical timepoint blood samples (baseline, cycle 2)\n* Uncontrollable grade ≥3 immune-related adverse events requiring permanent discontinuation of PD-1 inhibitor\n\nStudy Termination Criteria:\n\n* Disease progression confirmed by imaging per RECIST 1.1 or clinical progression requiring radiotherapy\n* Death or loss to follow-up \\>6 months\n* Unacceptable grade 4 treatment-related toxicity\n* Investigator determination that continued participation poses health risk to patient\n* Study terminated by ethics committee for scientific or administrative reasons","ALL","18 Years","80 Years",{"count":35,"type":36},80,"ESTIMATED","24 Months","OBSERVATIONAL","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:\n\n* Evaluate the relationship between ΔETAST levels (baseline to cycle 2) and progression-free survival\n* Compare the predictive performance of ΔETASTs with traditional biomarkers (PD-L1, TMB)\n* Assess whether ΔETASTs can identify patients more likely to benefit from PD-1 inhibitor plus chemotherapy\n\nParticipants will:\n\n* Provide peripheral blood samples at baseline and after cycle 2 of treatment\n* Undergo ETAST quantification using the CTT-NanoDT technology with TATAN nanoparticles\n* Have standard tumor assessments every 2 cycles according to RECIST 1.1 criteria\n* Be followed for progression-free survival and overall survival up to 24 months",[41,42,43,44,45,46],"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",[48,49,50,51,52],"Tumor Antigen-Specific T Cells","Effector T Cells","Circulating T Cells","Biomarkers","PD-1 Inhibitor","NOT_YET_RECRUITING","2026-02-02",{"date":56,"type":57},"2026-02-06","ACTUAL",{"date":59,"type":36},"2026-04",{"date":61,"type":36},"2029-06",{"name":5,"class":6}]