RecruitingPhase 2Phase 3NCT07034326

Electroacupuncture Combined With Immune Checkpoint Inhibitors as Adjuvant Therapy After Surgery for Early-stage Non-small Cell Lung Cancer

Observation on the Clinical Efficacy of Electroacupuncture Combined With Immune Checkpoint Inhibitors as Adjuvant Therapy After Surgery for Early-stage Non-small Cell Lung Cancer

Sponsor

Kong Fanming

Enrollment

405 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer Electroacupuncture Immune Checkpoint Inhibitors

Summary

Postoperative immunoadjuvant therapy has been proven to significantly reduce the risk of recurrence after resectable NSCLC, and has become a new standard of postoperative adjuvant therapy for stage II-III NSCLC. Immunotherapy faces challenges such as immune resistance, heterogeneity of biomarker expression, and limitation of immune-suitable population. How to reduce the rate of recurrence and metastasis after surgery, enhance the therapeutic effect of immunotherapy, and then prolong the survival period and improve the quality of life, has become an urgent problem facing the current clinical. Based on the standards of evidence-based medicine, this study for the first time carried out a large sample, multi-center, randomized parallel controlled clinical study to obtain high-quality clinical evidence of the effectiveness and safety of electro-acupuncture and Zilongjin tablet synergic treatment, and formed a standard treatment plan of traditional Chinese medicine.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding electroacupuncture (acupuncture with mild electrical stimulation) to standard immunotherapy (immune checkpoint inhibitor drugs) improves outcomes for patients who have had surgery for early-stage non-small cell lung cancer (NSCLC) and completed chemotherapy. **You may be eligible if...** - You have been diagnosed with Stage II, IIIA, or IIIB (N2) non-small cell lung cancer confirmed by pathology or cell testing, after surgery - Your cancer does not have driver mutations (EGFR, ALK, etc.) - You have completed 1 to 4 cycles of standard post-surgical chemotherapy - You match a traditional Chinese medicine pattern called "two qi syndrome" - You are between 18 and 80 years old - Your expected survival is more than 6 months - Your overall health status (ECOG) is 0–2 **You may NOT be eligible if...** - You have other active cancers - You have conditions that make acupuncture or immunotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERElectroacupuncture combined with immunotherapy

Connect the electroacupuncture therapy instrument, select the density wave 2 Hz/100 Hz, the current intensity should be tolerated by the patient, leave the needle for 20 min.Immunotherapy including but not limited to pabolizumab and attilizumab were repeated every 21 days for treatment weeks.The period is 1 year, and maintenance treatment can be carried out in accordance with the drug instructions and guidelines.

DRUGZilongjin tablet combined with immunotherapy

Take Zilongjin tablets orally, 4 tablets each time, 3 times a day.Immunotherapy including but not limited to pabolizumab and attilizumab were repeated every 21 days for treatment weeks.The period is 1 year, and maintenance treatment can be carried out in accordance with the drug instructions and guidelines.

DRUGImmunotherapy

Immunotherapy including but not limited to pabolizumab and attilizumab were repeated every 21 days for treatment weeks.The period is 1 year, and maintenance treatment can be carried out in accordance with the drug instructions and guidelines.