NCT07239661 Electroacupuncture Combined With PD-1 Inhibitor for ECOG2 Advanced NSCLC

Trial Parameters

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Brief Summary

The aim of this study was to systematically evaluate the clinical efficacy and safety of electroacupuncture (EA) combined with PD-1 inhibitors in patients with advanced non-small cell lung cancer (NSCLC) who have an ECOG performance status of 2 through a multicenter, randomized, sham-controlled clinical trial. The core scientific question addressed in this study was whether EA combined with standard immunotherapy could further improve progression-free survival (PFS), immune function, and quality of life in these patients. Patients meeting the inclusion criteria were randomly assigned in a 1:1 ratio to receive EA plus a PD-1 inhibitor (trial group) or sham EA plus a PD-1 inhibitor (control group) through a computerized randomization system. PD-1 inhibitors were administered every 21 days for four to six cycles, followed by maintenance therapy according to each patient's condition. EA intervention was initiated on the first day of each immunotherapy cycle and administered once daily for five sessions per cycle, continuing for four to six cycles. The primary endpoint was progression-free survival (PFS). The secondary endpoints included objective response rate (ORR), overall survival (OS), first-line treatment completion rate, quality of life as assessed by the EORTC QLQ-C30 scale, traditional Chinese medicine (TCM) syndrome score, immune function index, and incidence of adverse events according to CTCAE 5.0 criteria. In addition, peripheral blood was collected from patients at baseline for non-coding RNA sequencing, and differentially expressed genes were identified through bioinformatics analysis to determine potential molecular biomarkers associated with the synergistic effects of EA, thereby providing a basis for accurately identifying patients likely to benefit from EA therapy.

Eligibility Criteria

Inclusion Criteria: * Patients diagnosed with stage ⅢB-Ⅳ non-small cell lung cancer (NSCLC) confirmed by pathological or cytological examination; * Patients with negative driver gene mutations, excluding those harboring EGFR mutations, ALK rearrangements, or other common driver gene alterations as determined by genetic testing or other molecular biological methods; * An Eastern Cooperative Oncology Group (ECOG) performance status score of 2; * A programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥ 1%; * An expected survival time of more than 3 months, as assessed by the clinician based on the patient's overall condition, tumor progression, and response to treatment; * Patients with good treatment compliance who provided written informed consent, confirming their understanding of and willingness to undergo treatment and follow-up according to the study protocol. Exclusion Criteria: * Patients with a history or concurrent diagnosis of other malignant tumors within the past fi

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