NCT07086300

Electroacupuncture Combined With PD-1 Inhibitor for Elderly Patients With Advanced NSCLC

Clinical Study of Electroacupuncture Combined With PD-1 Inhibitor Treatment for Elderly Patients With Advanced Non-small Cell Lung Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Kong Fanming · Academic / Other
• Sex: All
• Age: 65 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is designed in accordance with the standards of evidence-based medicine, employing a multicenter, randomized controlled clinical trial framework. It aims to provide high-quality evidence regarding the clinical efficacy of acupuncture combined with PD-1 inhibitors in elderly patients with advanced NSCLC. Acupuncture has been shown to exert bidirectional regulatory effects on the tumor immune microenvironment. This study seeks to elucidate the predictive biomarkers through which acupuncture synergizes with immune checkpoint inhibitors to improve clinical outcomes in elderly patients with advanced NSCLC. Additionally, it explores the clinical and biological characteristics of the patient population that may derive the greatest benefit from this combined therapeutic approach.

Conditions

• Elderly Patients (>65 Years)
• Non-Small Cell Lung Cancer
• PD-1 Inhibitors
• Electroacupuncture

Interventions

Type	Name	Description
OTHER	Electroacupuncture (EA)	In the electroacupuncture group, bilateral Zusanli (ST36) and Sanyinjiao (SP6) points were selected for needling. Upon achieving the "deqi" sensation, the electroacupuncture device was connected to the needles at both points. A dispersed-dense wave was applied with an intensity ranging from 0.5 to 2 mA, adjusted according to the patient's tolerance. The needles were retained for 20 minutes, after which they were removed.
OTHER	Sham electroacupuncture	In the sham electroacupuncture group, bilateral Zusanli (ST36) and Sanyinjiao (SP6) points were selected for sham electroacupuncture intervention, which did not receive manual manipulation. The electrode placement and other treatment settings were identical to those in the electroacupuncture group, but no skin penetration, electrical output, or needle techniques were applied to induce the sensation of "deqi." No genuine electroacupuncture stimulation was administered in this group.

Timeline

• Start date: 2025-07-08
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-07-25
• Last updated: 2025-07-25

Locations

1 site across 1 country: China