Actively Recruiting
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
Led by Kong Fanming · Updated on 2025-06-24
405
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Kong Fanming
Lead Sponsor
M
Ministry of Science and Technology of the People´s Republic of China
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of electroacupuncture combined with immune checkpoint inhibitors as a postoperative adjuvant therapy for patients with early-stage non-small cell lung cancer (NSCLC). This study aims to address challenges such as immune resistance and biomarker variability, which affect immunotherapy outcomes. It is a large, multi-center, randomized clinical trial designed to provide high-quality evidence on the effectiveness and safety of combining traditional Chinese medicine with immunotherapy to reduce cancer recurrence and improve patients' quality of life after surgery. The study compares three treatment approaches: electroacupuncture combined with immunotherapy, Zilongjin tablet combined with immunotherapy, and immunotherapy alone. Electroacupuncture involves using an instrument delivering specific electrical stimulation to acupuncture points for 20 minutes per session. The Zilongjin tablet is taken orally at a dose of 4 tablets three times daily. Immunotherapy drugs, including but not limited to pabolizumab and attilizumab, are administered every 21 days for one year, with maintenance treatment based on drug guidelines. Participants will be monitored for disease-free survival at 2 years as the primary outcome, with additional follow-ups to 5 years for overall survival and quality of life assessments using the EORTC QLQ-C30 scale. Immune function and lung cancer traditional Chinese medicine syndrome scores will also be evaluated at multiple time points. The total participation period includes one year of treatment and extended observation, during which adherence and safety will be closely monitored.
CONDITIONS
Brief Title
Electroacupuncture Combined With Immune Checkpoint Inhibitors as Adjuvant Therapy After Surgery for Early-stage Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with stage I, IIA, or IIB (N2) non-small cell lung cancer after surgery confirmed by pathology or cytology
- Negative for driver mutations
- Completed 1 to 4 cycles of postoperative adjuvant chemotherapy
- Meet two qi syndrome criteria of traditional Chinese medicine syndrome differentiation
- Aged between 18 and 80 years old
- Expected to live longer than 6 months
- ECOG performance status between 0 and 2
- Willing to accept the treatment and adhere well to the protocol
You will not qualify if you...
- History of other malignant tumors within the past 5 years or currently
- Serious heart, liver, kidney damage, or other serious complications
- Patients with R1 or R2 resection or those needing postoperative adjuvant radiotherapy
- Presence of mental disorders
- Known drug allergies or allergic constitution
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants receive immunotherapy every 21 days combined with either electroacupuncture or Zilongjin tablets as adjuvant therapy after surgery. The treatment period is 1 year, with maintenance treatment according to drug instructions and guidelines.
Visits every 3 weeks during treatment
Duration - Up to 5 years
Participants are followed for disease-free survival and overall survival, with assessments including quality of life, immune function, and lung cancer syndrome scores up to 5 years after treatment.
Follow-up visits at 0, 2, 3, and 6 months, then yearly assessments
Trial Site Locations
Total: 1 location
1
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, China, 300381
Actively Recruiting
Research Team
F
Fanming Kong Director of Oncology Department, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here