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

Launched by WEST CHINA HOSPITAL · Jul 11, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether adding a special type of acupuncture called electroacupuncture at a specific point on the leg (called Zusanli or ST36) can help improve the effects of immunotherapy in people with lung cancer. Immunotherapy is a treatment that helps the immune system fight cancer, but it doesn’t always work well on its own. Acupuncture, which comes from traditional Chinese medicine, may help by boosting the body’s immune response and reducing inflammation. This study will test if combining these two treatments is safe and if it makes immunotherapy work better for patients with non-small cell lung cancer.

People who might join this study are adults between 18 and 80 years old who have been diagnosed with certain types of lung cancer and are already receiving standard treatment that includes chemotherapy and immunotherapy. Participants should be in generally good health with a life expectancy of more than three months and have measurable tumors seen on scans. During the study, they will receive electroacupuncture treatments for three days in a row, where gentle electrical stimulation is applied to the acupuncture point on the leg. The goal is to see if this helps activate the immune system and improves how well the cancer treatment works. It’s important that participants do not have certain health conditions like severe heart problems or infections at the acupuncture site, and they must be willing to follow the study procedures and attend follow-up visits.

Gender

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Eligibility criteria

• 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 extensive-stage small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC) receiving neoadjuvant immunotherapy;
• • 3. Undergoing standard first-line 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.