💬In plain words
What the trial is, and whether it could suit you
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 suc
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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