NCT07076836

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

Not yet recruiting NA Last updated 22 July 2025

What this trial tests

NA trial testing Acupuncture in Lung Cancer (NSCLC) in 82 participants. Not yet recruiting.

Timeline

31 July 2025

Primary endpoint
30 June 2026

30 June 2026

Quick facts

Lead sponsor	West China Hospital
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	82
Start date	31 July 2025
Primary completion	30 June 2026
Estimated completion	30 June 2026
Sites	1 location across China

Drugs / interventions tested

• Acupuncture — full drug profile →
• sham acupuncture

Conditions studied

• Lung Cancer (NSCLC) — all drugs for Lung Cancer (NSCLC) →
• Small Cell Lung Cancer ( SCLC ) — all drugs for Small Cell Lung Cancer ( SCLC ) →
• Immune Checkpoint Blockade — all drugs for Immune Checkpoint Blockade →
• Electroacupuncture — all drugs for Electroacupuncture →

Sponsor

West China Hospital

Who can join

Adults 18 to 80, any sex, with Lung Cancer (NSCLC) or Small Cell Lung Cancer ( SCLC ). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Research progress on traditional Chinese medicine-assisted immune checkpoint inhibitors therapy for solid tumors.
   Liu Z, Xie Y, He Y, Chen K, et al · · 2026 · PMID 41694353 · DOI 10.3389/fimmu.2026.1723860