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

NCT ID: NCT07086300

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-08
• Study Completion Date: 2028-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Electroacupuncture (EA)

Intervention Type: OTHER

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.

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.

Group Type: SHAM_COMPARATOR

Sham electroacupuncture

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients with a history of or concurrent other malignancies within the past 5 years.
• Patients with severe organ dysfunction or other serious comorbidities, such as heart failure (NYHA Class III-IV), hepatic or renal insufficiency, as assessed by routine examinations including liver function tests, renal function tests, and electrocardiograms.
• Patients with untreated central nervous system metastases. Only those who have undergone at least one course of systemic or surgical treatment and have been confirmed to have stable disease by imaging studies will be included.
• Patients with psychiatric disorders, including a history of severe mental illnesses (e.g., schizophrenia, bipolar disorder) that require pharmacological treatment for control.
• Patients with a history of multiple drug allergies or an allergic constitution, particularly those who have experienced severe allergic reactions such as anaphylactic shock or allergic rashes.
• Patients with active autoimmune diseases or infectious diseases, including but not limited to active or chronic viral hepatitis, active pulmonary tuberculosis, or other infectious or autoimmune conditions deemed by the clinical investigator to potentially affect the study.
• Patients who are pregnant or breastfeeding.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kong Fanming

OTHER

Sponsor Role: lead

Responsible Party

Kong Fanming

Director of Oncology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fanming Kong, PhD

Role: CONTACT

kongfanming08@163.com

+86 22 27986525

Facility Contacts

Fanming Kong, PhD

Role: primary

kongfanming08@163.com

+86 22 27986525

Other Identifiers

TYLL2025[K]049

Identifier Type: -

Identifier Source: org_study_id