Evaluating Electroacupuncture with PD-1 Inhibitors for Advanced Non-Small Cell Lung Cancer in Patients with ECOG Performance Status 2

What this Trial Is About

Researchers are evaluating the clinical efficacy and safety of combining electroacupuncture EA with PD-1 inhibitors in patients with advanced non-small cell lung cancer NSCLC who have an Eastern Cooperative Oncology Group ECOG performance status of 2. This multicenter, randomized, sham-controlled trial aims to determine whether adding EA to standard immunotherapy can improve progression-free survival PFS, immune function, and quality of life in these patients. The study also seeks to identify molecular biomarkers that may predict which patients could benefit from EA therapy. Participants are randomly assigned to one of two groups one receiving electroacupuncture plus PD-1 inhibitor treatment, and the other receiving sham electroacupuncture plus PD-1 inhibitor treatment. PD-1 inhibitors are administered every 21 days for four to six cycles, followed by maintenance therapy tailored to each patients condition. Electroacupuncture or sham treatment is given once daily for five sessions during each immunotherapy cycle, with treatments synchronized for four to six cycles. Electroacupuncture involves stimulation at specific acupoints with electrical current, while sham treatment mimics the procedure without needle penetration or electrical stimulation. During the study, participants undergo regular assessments including progression-free survival monitoring, immune function tests, and quality of life evaluations using the EORTC QLQ-C30 scale. Peripheral blood samples are collected at baseline to analyze gene expression related to treatment response. Researchers track adverse events using established criteria throughout the trial. The primary outcome is progression-free survival, measured from enrollment until disease progression or death. The study may last up to 100 months for outcome assessment and includes close monitoring to ensure participant safety and adherence to the treatment protocol.

Electroacupuncture Combined With PD-1 Inhibitor for ECOG2 Advanced NSCLC