Actively Recruiting
Clinical Study of Electroacupuncture Combined With PD-1 Inhibitor Treatment for Elderly Patients With Advanced Non-small Cell Lung Cancer
Led by Kong Fanming · Updated on 2025-07-25
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical efficacy and safety of combining electroacupuncture with PD-1 inhibitor therapy in elderly patients aged 65 and older who have advanced non-small cell lung cancer (NSCLC). This multicenter, randomized controlled trial aims to determine if adding electroacupuncture to PD-1 inhibitors improves treatment outcomes and safety compared to PD-1 inhibitors combined with sham electroacupuncture. The study also explores biomarkers to identify which patients may benefit most from this combined approach. Participants will be randomly assigned to one of two groups: one receiving electroacupuncture plus PD-1 inhibitor therapy, and the other receiving sham electroacupuncture plus PD-1 inhibitor therapy. The PD-1 inhibitor is given in cycles every 21 days, with 4 to 6 treatment cycles followed by optional maintenance therapy. Electroacupuncture or sham treatments start on the same day as the PD-1 inhibitor cycle, administered once daily for five sessions per cycle, lasting 20 minutes each, targeting specific acupuncture points. During the study, participants will undergo evaluations including progression-free survival as the primary outcome, with additional measures such as response rate, quality of life, immune function, and traditional Chinese medicine syndrome scores. Safety is closely monitored. Peripheral non-coding RNA samples will be collected at the start to study gene expression related to treatment response. The study duration and follow-up span up to 100 months for outcome assessment.
CONDITIONS
Brief Title
Electroacupuncture Combined With PD-1 Inhibitor for Elderly Patients With Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with stage IIIB-IV non-small cell lung cancer confirmed by histopathological or cytological diagnosis.
- Patients with negative driver gene mutations, excluding common mutations like EGFR and ALK.
- Patients aged 65 years or older, with good overall physical condition.
- PD-L1 tumor proportion score of 1% or higher.
- Estimated survival time greater than 3 months.
- ECOG performance status score between 0 and 2.
- Patients willing to comply with treatment and follow-up and able to sign informed consent.
You will not qualify if you...
- History of or concurrent other malignancies within the past 5 years.
- Severe organ dysfunction or serious comorbidities, such as advanced heart failure or liver/kidney insufficiency.
- Untreated central nervous system metastases; only stable disease after treatment allowed.
- Psychiatric disorders requiring medication, including severe mental illnesses.
- History of multiple drug allergies or severe allergic reactions.
- Active autoimmune or infectious diseases that could affect the study.
- 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 - 4 to 6 immunotherapy cycles
Participants receive electroacupuncture or sham electroacupuncture once daily for five sessions during each immunotherapy cycle. This treatment is synchronized with PD-1 inhibitor immunotherapy cycles.
Daily visits for 5 days per cycle
Duration - Up to 100 months
Participants are monitored for disease progression or survival after completing treatment.
Visits scheduled as per clinical follow-up
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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