Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT07086300 for Elderly Patients (>65 Years), Non-Small Cell Lung Cancer, PD-1 Inhibitors, Electroacupuncture is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Electroacupuncture Combined With PD-1 Inhibitor for Elderly Patients With Advanced NSCLC 120 Same-Day Visits Biomarker-Driven Randomized Senior-Focused
Clinical Trial NCT07086300 is an interventional study for Elderly Patients (>65 Years), Non-Small Cell Lung Cancer, PD-1 Inhibitors, Electroacupuncture that is recruiting. It started on 8 July 2025 with plans to enroll 120 participants. Led by Kong Fanming, it is expected to complete by 31 December 2028. The latest data from ClinicalTrials.gov was last updated on 25 July 2025.
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 ...Show More
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 microenvironme...
Show MoreOfficial Title
Clinical Study of Electroacupuncture Combined With PD-1 Inhibitor Treatment for Elderly Patients With Advanced Non-small Cell Lung Cancer
Conditions
Elderly Patients (>65 Years)Non-Small Cell Lung CancerPD-1 InhibitorsElectroacupunctureOther Study IDs
- TYLL2025[K]049
NCT ID Number
Start Date (Actual)
2025-07-08
Last Update Posted
2025-07-25
Completion Date (Estimated)
2028-12-31
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
electroacupuncture
Elderly patients
non-small cell lung cancer
Immunotherapy
immune checkpoint inhibitor
Elderly patients
non-small cell lung cancer
Immunotherapy
immune checkpoint inhibitor
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalElectroacupuncture 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 i...Show More | 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 remo...Show More |
Sham ComparatorSham 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 ident...Show More | 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 genu...Show More |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
progression-free survival | Defined as the interval from the time of enrollment to the first documentation of disease progression or death from any cause. | 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. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Older Adult
Minimum Age
65 Years
Eligible Sexes
All
- 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.
- 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.
Kong FanmingStudy Responsible Party
Kong Fanming, Sponsor-Investigator, Director of Oncology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Study Central Contact
Contact: Fanming Kong, PhD, +86 22 27986525, [email protected]
1 Study Locations in 1 Countries
Tianjin Municipality
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, Tianjin Municipality, 300193, China
Fanming Kong, PhD, Contact, +86 22 27986525, [email protected]
Recruiting