Zusanli (ST36) Electroacupuncture Treatment for Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer

This study aims to investigate the potential synergistic effects of acupuncture combined with immune checkpoint inhibitors in cancer therapy. Over the past decade, significant progress in cancer immunotherapy has been driven by breakthroughs in understanding immune checkpoint molecules; however, monotherapy with immune checkpoint inhibitors still faces challenges due to low response rates. As a traditional Chinese medical intervention, acupuncture modulates neuro-immune pathways to achieve remote regulation of organ functions, with particular anti-tumor potential observed at the Zusanli (ST36) acupoint-a site located 2 cm below the knee that can be stimulated via electroacupuncture (EA) to improve gastrointestinal function and alleviate inflammation. Preclinical evidence demonstrates that EA suppresses tumor growth in breast cancer models, reduces levels of pro-inflammatory cytokines such as IL-1β and TNF-α, enhances anti-tumor activity of CD8+ T cells and NK cells, and decreases accumulation of immunosuppressive myeloid-derived suppressor cells (MDSCs). Animal studies show that ST36 EA increases key immunomodulatory factors like serum IFN-γ, IL-2, and IL-17, thereby potentiating the efficacy of anti-tumor drugs. Guided by the traditional TCM principle of "reinforcing healthy qi to consolidate the body's resistance," modern clinical applications of EA combined with specific acupoint regimens (e.g., ST36, Sanyinjiao) have effectively alleviated cancer-related pain, chemotherapy-induced side effects, and fatigue. This study will evaluate the safety and immunosensitization effects of ST36 EA combined with PD-1 inhibitors in non-small cell lung cancer patients, employing 1 mA electroacupuncture for 3 consecutive days to activate immune responses. By leveraging acupuncture-induced immune remodeling, this approach aims to provide a novel integrative medicine strategy to overcome resistance to immunotherapy.

NCT Number	NCT07076836
Lead Sponsor	West China Hospital
Conditions	Lung Cancer (NSCLC), Small Cell Lung Cancer ( SCLC ), Immune Checkpoint Blockade, Electroacupuncture
Enrollment	82 participants
Start Date	2025-07-31
Primary Completion	2026-06-30 (estimated)
Study Completion	2026-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-07-22