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NCT Number: NCT07034326

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Electroacupuncture Immune Checkpoint Inhibitors Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, 300381, China

Location status: Recruiting

Location contact

Fanming Kong Fanming Kong, PhD

CONTACT

[email protected]

+ 86 22 27986525

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (1) Non-tumor patients with stage Ⅱ, ⅢA, ⅢB (N2) non-small cell lung cancer diagnosed by pathology or cytology after surgery; (2) driver mutations negative patients; (3) Postoperative adjuvant chemotherapy was received for 1 to 4 cycles;(4)conforms to two qi syndrome of traditional Chinese medicine syndrome differentiation diagnosis of patients; (5) aged 18 to 80 years old; (6) expected lifetime > 6 months; (7) ECOG 0 to 2 points; (8) patients willing to accept this solution treatment, adherence to the good.

Exclusion criteria

  • (1) Patients with other malignant tumors in the past or at the same time within 5 years; (2) has a serious heart, liver and kidney damage, or other serious complications; (3) the R1, R2, need after resection, postoperative adjuvant radiotherapy patients; (4) with mental disorders; (5) has a variety of drug allergy, allergic constitution; (6) in pregnancy or lactation women.

Treatment and study plan

Electroacupuncture combined with immunotherapy

Other

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.

Zilongjin tablet combined with immunotherapy

Drug

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.

Immunotherapy

Drug

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.

Primary outcomes

  1. Disease free survival(DFS)

    Time frame: 2year

    Time from random start to first recurrence or death.

Secondary outcomes

  1. DFS

    Time frame: 3year

    Time from random start to first recurrence or death.

  2. Overall survival

    Time frame: 3,5year

  3. EORTC QLQ-C30 Scale

    Time frame: 0,2,3,6 month

    EORTC QLQ-C30 Scale

  4. Immune function

    Time frame: 0,3 month

    T lymphocyte subsets, NK cells

  5. Lung cancer TCM syndrome score

    Time frame: 0,2,3,6 month

Study contacts

Contact information is provided by the study sponsor or research team.

Fanming Kong Director of Oncology Department, PhD

CONTACT

[email protected]

+ 86 22 27986525

Sponsors and collaborators

Lead sponsor

Kong Fanming

Other

Collaborators

  • Ministry of Science and Technology of the People´s Republic of China

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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