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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• progression-free survival [Time frame: Defined as the time interval from the date of enrollment to the first documented occurrence of disease progression or death from any cause, whichever comes first. This outcome will be assessed up to 100 months.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine — Tianjin

Identifiers

NCT: NCT07086300 · TYLL2025[K]049

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗