Actively Recruiting
Clinical Efficacy of Electroacupuncture Combined With PD-1 Inhibitor for ECOG2 Advanced Non-Small Cell Lung Cancer
Led by Kong Fanming · Updated on 2025-11-20
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical efficacy and safety of combining electroacupuncture (EA) with PD-1 inhibitors in patients with advanced non-small cell lung cancer (NSCLC) who have an Eastern Cooperative Oncology Group (ECOG) performance status of 2. This multicenter, randomized, sham-controlled trial aims to determine whether adding EA to standard immunotherapy can improve progression-free survival (PFS), immune function, and quality of life in these patients. The study also seeks to identify molecular biomarkers that may predict which patients could benefit from EA therapy. Participants are randomly assigned to one of two groups: one receiving electroacupuncture plus PD-1 inhibitor treatment, and the other receiving sham electroacupuncture plus PD-1 inhibitor treatment. PD-1 inhibitors are administered every 21 days for four to six cycles, followed by maintenance therapy tailored to each patient's condition. Electroacupuncture or sham treatment is given once daily for five sessions during each immunotherapy cycle, with treatments synchronized for four to six cycles. Electroacupuncture involves stimulation at specific acupoints with electrical current, while sham treatment mimics the procedure without needle penetration or electrical stimulation. During the study, participants undergo regular assessments including progression-free survival monitoring, immune function tests, and quality of life evaluations using the EORTC QLQ-C30 scale. Peripheral blood samples are collected at baseline to analyze gene expression related to treatment response. Researchers track adverse events using established criteria throughout the trial. The primary outcome is progression-free survival, measured from enrollment until disease progression or death. The study may last up to 100 months for outcome assessment and includes close monitoring to ensure participant safety and adherence to the treatment protocol.
CONDITIONS
Brief Title
Electroacupuncture Combined With PD-1 Inhibitor for ECOG2 Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with stage IIB-IV non-small cell lung cancer confirmed by pathology or cytology
- Negative for driver gene mutations such as EGFR and ALK
- ECOG performance status score of 2
- PD-L1 tumor proportion score (TPS) of 1% or higher
- Expected survival time longer than 3 months as assessed by a clinician
- Able and willing to comply with study treatment and follow-up, with informed consent provided
You will not qualify if you...
- History or current diagnosis of other malignant tumors within the last 5 years
- Severe organ impairment or serious comorbidities including NYHA class II-III cardiac dysfunction, liver or kidney insufficiency
- Untreated central nervous system metastases; only stable CNS disease after treatment allowed
- Psychiatric disorders requiring medication, such as schizophrenia or bipolar disorder
- History of multiple drug allergies or severe allergic reactions like anaphylaxis
- Active autoimmune or infectious diseases, including chronic viral hepatitis or tuberculosis
- 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 - Duration of 4 to 6 immunotherapy cycles
Participants receive electroacupuncture or sham electroacupuncture combined with PD-1 inhibitor immunotherapy. Electroacupuncture is administered once daily for five sessions per immunotherapy cycle, with a total of 4 to 6 cycles.
Daily visits for 5 consecutive days per cycle, for 4 to 6 cycles
Duration - Up to 100 months
Participants are monitored for progression-free survival and other clinical outcomes following treatment completion.
Periodic visits for outcome assessment
Trial Site Locations
Total: 1 location
1
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China, 300193
Actively Recruiting
Research Team
F
Fanming Kong, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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