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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWest China Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 and ≤80 years at the time of written informed consent, of either sex;

Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) receiving neoadjuvant immunotherapy;

Undergoing standard neoadjuvant treatment with chemotherapy plus immunotherapy

ECOG performance status score of 0-2;

Disqualifiers

Pregnant participants;

Post-organ transplant patients;

Patients with uncontrolled diabetes mellitus, severe cardiac, central nervous system, psychiatric disorders, or coagulopathy;

Patients with severe malnutrition;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acupuncture

    Device

    The electroacupuncture parameters were set as follows: frequency at 10 Hz, current intensity at 0.5 mA, pulse width at 50 μs, and each session lasted 30 minutes. On the first day of chemotherapy, electroacupuncture was administered 1-2 hours prior to chemotherapy initiation. From Day 2 to the final day of chemotherapy, electroacupuncture sessions were conducted daily between 2:00 PM and 4:00 PM.

  • sham acupuncture

    Device

    The sham electroacupuncture group referenced the same acupoints as the electroacupuncture group, but the false acupoint shallow needling method and false electrode method are used, and the treatment time and course are the same as the electroacupuncture group.

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Electroacupuncture groupExperimental treatment 1 intervention
Group B: Sham electroacupuncture groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Neoadjuvant Immunotherapy Conversion Rate

Time frame
Baseline, After neoadjuvant immunotherapy (2-3 cycle, about 2 months after baseline)

Secondary outcomes

1

Peripheral blood immune cell alterations

Peripheral blood immune cell alterations assessed by flow cytometry: CD4+/CD8+ T-cell ratio, Tregs, and NK cell subsets

Time frame
Baseline (Day 1), end of Cycle 1 (21 days), Cycle 2 (42 days), and Cycle 3 (63 days). Each immunotherapy cycle is 21 days
2

Serum and Urine dopamine pathway and metabolites

Serum norepinephrine and epinephrine concentrations analyzed via mass spectrometry

Time frame
Baseline (Day 1), end of Cycle 1 (21 days), Cycle 2 (42 days), and Cycle 3 (63 days). Each immunotherapy cycle is 21 days

Other outcomes

Sponsors and contacts

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