Study of Electroacupuncture and Zilongjin Tablet Combined With Immune Checkpoint Inhibitors as Post-Surgery Adjuvant Treatment for Early-Stage Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the use of electroacupuncture combined with immune checkpoint inhibitors as a postoperative adjuvant therapy for patients with early-stage non-small cell lung cancer NSCLC. This study aims to address challenges such as immune resistance and biomarker variability, which affect immunotherapy outcomes. It is a large, multi-center, randomized clinical trial designed to provide high-quality evidence on the effectiveness and safety of combining traditional Chinese medicine with immunotherapy to reduce cancer recurrence and improve patients quality of life after surgery. The study compares three treatment approaches electroacupuncture combined with immunotherapy, Zilongjin tablet combined with immunotherapy, and immunotherapy alone. Electroacupuncture involves using an instrument delivering specific electrical stimulation to acupuncture points for 20 minutes per session. The Zilongjin tablet is taken orally at a dose of 4 tablets three times daily. Immunotherapy drugs, including but not limited to pabolizumab and attilizumab, are administered every 21 days for one year, with maintenance treatment based on drug guidelines. Participants will be monitored for disease-free survival at 2 years as the primary outcome, with additional follow-ups to 5 years for overall survival and quality of life assessments using the EORTC QLQ-C30 scale. Immune function and lung cancer traditional Chinese medicine syndrome scores will also be evaluated at multiple time points. The total participation period includes one year of treatment and extended observation, during which adherence and safety will be closely monitored.

Electroacupuncture Combined With Immune Checkpoint Inhibitors as Adjuvant Therapy After Surgery for Early-stage Non-small Cell Lung Cancer