NCT07076836Recruiting
Zusanli (ST36) Electroacupuncture Treatment for Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- First submitted
- 26 Jun 2025
- Start date
- 31 Aug 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- West China Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07076836
What you commit to
- Study type: Interventional
- Planned participants: 82
- From 31 Aug 2026 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Post-organ transplant patients;
Other illness
- Patients with uncontrolled diabetes mellitus, severe cardiac, central nervous system, psychiatric disorders, or coagulopathy;
- Patients with implanted cardiac pacemakers;
- Patients with bleeding disorders;
- Patients with a history of severe allergies or anaphylaxis;
- Patients with skin infections, lesions, ulcers, or scars at the ST36 (Zusanli) acupoint site;
- Patients with metal allergy, severe needle phobia, or intolerance to electroacupuncture therapy.
Other
- Pregnant participants;
- Patients with severe malnutrition;
Who the study is looking for
- 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;
- Life expectancy \>3 months;
- At least one measurable target lesion per RECIST 1.1 criteria:
- Tumor lesions with a long axis ≥10 mm on CT scan (slice thickness ≤5 mm);
- Lymph node lesions with a short axis ≥10 mm on CT scan;
- Previously irradiated or locally treated lesions may be designated as target lesions if documented tumor progression post-treatment.
- Adequate major organ function within 14 days prior to randomization, defined by the following laboratory parameters without blood transfusions, growth factors, albumin, or blood products:
- Hematological tests: Hemoglobin ≥80 g/L; Absolute neutrophil count \>1.5×10⁹/L; Platelet count ≥90×10⁹/L;
- Biochemical tests: Total bilirubin ≤1.5×ULN (upper limit of normal); ALT/AST ≤2.5×ULN; Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (Cockcroft-Gault formula);
- Coagulation tests: Prothrombin time (PT) and INR ≤1.5×ULN (unless on warfarin anticoagulation);
- Cardiac evaluation: Left ventricular ejection fraction (LVEF) ≥50% by Doppler echocardiography.
- Voluntary participation with signed informed consent, good compliance, and willingness of the patient and their family to cooperate with survival follow-up.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.