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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 100
Healthy Volunteers: f
View:

• Patients with stage IIIB-IV non-small cell lung cancer (NSCLC) confirmed by histopathological or cytological diagnosis.

• Patients with negative driver gene mutations, as determined by genetic testing or other molecular biological methods, to exclude common driver mutations such as EGFR mutations and ALK rearrangements.

• Patients aged ≥65 years, with consideration for the patients' overall physical condition. Additional assessments will be conducted if there are comorbidities or other factors that may affect their physical status.

• PD-L1 tumor proportion score (TPS) ≥1%.

• Estimated survival time \>3 months, as determined by clinical evaluation based on the patient's overall condition, tumor progression, and response to treatment.

• ECOG performance status score of 0-2.

• Patients with good treatment compliance, who are willing to sign an informed consent form, indicating their understanding and agreement to adhere to the study protocol for treatment and follow-up.

Locations
Other Locations
China
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
RECRUITING
Tianjin
Contact Information
Primary
Fanming Kong, PhD
kongfanming08@163.com
+86 22 27986525
Time Frame
Start Date: 2025-07-08
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 120
Treatments
Experimental: Electroacupuncture group
Bilateral Zusanli (ST36) and Sanyinjiao (SP6) acupoints were selected. After obtaining deqi sensation upon needle insertion, an electroacupuncture device was connected to each of the selected acupoints. A sparse-dense wave mode was chosen, with an intensity ranging from 0.5 to 2 mA, adjusted according to patient tolerance. The needles were retained for 20 minutes before removal. The electroacupuncture treatment was initiated on the same day as the commencement of the immunotherapy cycle, administered once daily for a total of five sessions, ensuring that each immunotherapy cycle was synchronized with electroacupuncture treatment. The overall treatment consisted of 4 to 6 cycles.
Sham_comparator: Sham electroacupuncture group
Bilateral Zusanli (ST36) and Sanyinjiao (SP6) acupoints were selected. Electroacupuncture devices were connected to these acupoints. A sparse-dense wave mode was utilized, with an intensity ranging from 0.5 to 2 mA, and the needles were retained for 20 minutes before removal. In the sham electroacupuncture group, no manual manipulation was performed. The placement of electrodes and other treatment settings were identical to those in the electroacupuncture group, but without skin penetration, electrical output, or needling techniques to induce deqi. Electroacupuncture treatment was initiated on the same day as the start of the immunotherapy cycle, administered once daily for a total of five sessions, ensuring synchronization with each immunotherapy cycle. The overall treatment regimen consisted of 4 to 6 cycles.
Sponsors
Leads: Kong Fanming

This content was sourced from clinicaltrials.gov

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