Actively Recruiting
Electroacupuncture Combined With PD-1 Inhibitor for Elderly Patients With Advanced NSCLC
Led by Kong Fanming · Updated on 2025-07-25
120
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to elucidate the clinical efficacy and safety of electroacupuncture combined with PD-1 inhibitor therapy in elderly patients with advanced non-small cell lung cancer (NSCLC) through a multicenter, randomized controlled clinical trial. The main question it aims to answer is: the combination of electroacupuncture and PD-1 inhibitor therapy has demonstrated significant improvements in both clinical efficacy and safety profiles among elderly patients with advanced NSCLC. Researchers will compare a sham electroacupuncture group combined with PD-1 inhibitor therapy (serving as the control group) to see if the intervention group exhibits superior therapeutic efficacy and safety outcomes. Participants will be randomly assigned to one of two groups: an electroacupuncture combined with an immune checkpoint inhibitor group, or a sham electroacupuncture combined with an immune checkpoint inhibitor group. The immune checkpoint inhibitor will be administered on a 21-day cycle, with a total of 4 to 6 treatment cycles, followed by the option for maintenance therapy. Electroacupuncture treatment will commence on the same day as the initiation of the immune checkpoint inhibitor cycle, administered once daily for a total of five sessions per cycle, with 4 to 6 cycles in total. The primary outcome measure is progression-free survival (PFS). Secondary outcomes include objective response rate (ORR), quality of life, immune function, traditional Chinese medicine syndrome scores for lung cancer, and safety parameters. This study aims to establish the efficacy and safety of electroacupuncture combined with PD-1 inhibitors in elderly patients with advanced NSCLC. Additionally, peripheral non-coding RNA will be collected at baseline to analyze differentially expressed genes, thereby identifying molecular predictive biomarkers for patients who may benefit most from this combined treatment approach.
CONDITIONS
Official 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 such as EGFR mutations and ALK rearrangements
- Patients aged 65 years or older with consideration of overall physical condition
- PD-L1 tumor proportion score of 1% or higher
- Estimated survival time greater than 3 months based on clinical evaluation
- ECOG performance status score of 0 to 2
- Patients able to comply with treatment and follow-up and willing 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 NYHA Class III-IV heart failure, liver or kidney insufficiency
- Untreated central nervous system metastases; only stable disease after treatment allowed
- Psychiatric disorders requiring pharmacological treatment, including severe mental illnesses
- History of multiple drug allergies or severe allergic reactions such as anaphylactic shock
- Active autoimmune or infectious diseases including active viral hepatitis or tuberculosis
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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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
CONTACT
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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