Zusanli (ST36) electroacupuncture plus immunotherapy in NSCLC before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores the potential synergy between electroacupuncture at ST36 and neoadjuvant immunotherapy in NSCLC. Participants must have NSCLC and be receiving standard neoadjuvant chemotherapy plus immunotherapy. Acupuncture or sham acupuncture is used to assess any added benefit on treatment response and immune-related outcomes. The study is conducted at West China Hospital in Chengdu and uses predefined imaging and laboratory criteria to measure response and safety. The design seeks to determine if acupuncture can enhance anti-tumor immune activity alongside checkpoint inhibitors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 and ≤80 years at the time of written informed consent, of either sex;
2. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) receiving neoadjuvant immunotherapy;
3. Undergoing standard neoadjuvant treatment with chemotherapy plus immunotherapy
4. ECOG performance status score of 0-2;
5. Life expectancy \>3 months;
6. At least one measurable target lesion per RECIST 1.1 criteria:
7. Tumor lesions with a long axis ≥10 mm on CT scan (slice thickness ≤5 mm);
8. Lymph node lesions with a short axis ≥10 mm on CT scan;
9. Previously irradiated or locally treated lesions may be designated as target lesions if documented tumor progression post-treatment.
10. 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:
11. Hematological tests: Hemoglobin ≥80 g/L; Absolute neutrophil count \>1.5×10⁹/L; Platelet count ≥90×10⁹/L;
12. 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);
13. Coagulation tests: Prothrombin time (PT) and INR ≤1.5×ULN (unless on warfarin anticoagulation);
14. Cardiac evaluation: Left ventricular ejection fraction (LVEF) ≥50% by Doppler echocardiography.
15. Voluntary participation with signed informed consent, good compliance, and willingness of the patient and their family to cooperate with survival follow-up.

Exclusion Criteria:

1. Pregnant participants;
2. Post-organ transplant patients;
3. Patients with uncontrolled diabetes mellitus, severe cardiac, central nervous system, psychiatric disorders, or coagulopathy;
4. Patients with severe malnutrition;
5. Patients with implanted cardiac pacemakers;
6. Patients with bleeding disorders;
7. Patients with a history of severe allergies or anaphylaxis;
8. Patients with skin infections, lesions, ulcers, or scars at the ST36 (Zusanli) acupoint site;
9. Patients with metal allergy, severe needle phobia, or intolerance to electroacupuncture therapy.

Where it's running

• West China Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Nan Lin
• Email: sculinnan@qq.com
• Phone: +86 18708305692

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.