💬In plain words
What the trial is, and whether it could suit you
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 inte
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📋 Eligibility rules (as published)
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 five years;
* Patients with severe organ impairment or serious comorbidities, such as cardiac dysfunction (New York Heart Association \[NYHA\] class Ⅲ-Ⅳ), hepatic or renal insufficiency, as determined by standard clinical examinations including liver and kidney function tests and electrocardiography;
* Patients with untreated central nervous system (CNS) metastases were excluded; eligible patients were required to have stable disease confirmed by imaging after receiving at least one systemic or surgical treatment;
* Patients with psychiatric disorders, including schizophrenia or bipolar disorder, particularly those requiring pharmacologic treatment;
* Patients with a history of multiple drug allergies, an allergic predisposition, or a history of severe allergic reactions such as anaphylactic shock or allergic rash;
* Subjects with active autoimmune or infectious diseases, including but not limited to chronic viral hepatitis, active pulmonary tuberculosis, or other infections or autoimmune disorders deemed by clinicians to potentially affect the study;
* Female patients who were pregnant or lactating.
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