Elderly Patients (>65 Years)NCT07086300
Electroacupuncture Combined With PD-1 Inhibitor for Elderly Patients With Advanced NSCLC
A study testing Electroacupuncture (EA) in people with Elderly Patients (>65 Years) and Non-Small Cell Lung Cancer, run by Kong Fanming at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Elderly Patients (>65 Years), Non-Small Cell Lung Cancer, PD-1 Inhibitors
- What is being tested?
- Electroacupuncture (EA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300193
Fanming Kong, PhD, +86 22 27986525, kongfanming08@163.com
About this study
Official title: Clinical Study of Electroacupuncture Combined With PD-1 Inhibitor Treatment for Elderly Patients With Advanced Non-small Cell Lung Cancer
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.
Read the 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
- Being tested
- Electroacupuncture (EA), Sham electroacupuncture
- Keywords
- electroacupuncture, Elderly patients, non-small cell lung cancer, Immunotherapy, immune checkpoint inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture (EA)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 electroacupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture group | Experimental | 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. Receives: Other: Electroacupuncture (EA) |
| Sham electroacupuncture group | Sham comparator | 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. Receives: Other: Sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Defined as the interval from the time of enrollment to the first documentation of disease progression or death from any cause.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start8 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly Patients (>65 Years)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kong Fanming
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kong Fanming, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086300
- Sponsor's protocol ID
- TYLL2025[K]049
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This decision may stem from concerns regarding privacy or ethical issues associated with data sharing, or because the research data is considered proprietary and not intended for public disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Electroacupuncture Combined With PD-1 Inhibitor Treatment for Elderly Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07086300
- Acronym / sponsor ID
- TYLL2025[K]049
- Conditions
- Elderly Patients (>65 Years), Non-Small Cell Lung Cancer, PD-1 Inhibitors, Electroacupuncture
- Keywords
- electroacupuncture, Elderly patients, non-small cell lung cancer, Immunotherapy, immune checkpoint inhibitor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kong FanmingUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture group | Experimental | Other: Electroacupuncture (EA)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 electroacupuncture group | Sham comparator | Other: Sham electroacupunctureBilateral 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. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Electroacupuncture group |
| Sham electroacupunctureIn 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. | Other | Sham electroacupuncture group |
Primary outcome
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.
Defined as the interval from the time of enrollment to the first documentation of disease progression or death from any cause.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No. This decision may stem from concerns regarding privacy or ethical issues associated with data sharing, or because the research data is considered proprietary and not intended for public disclosure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture (EA) in people with Elderly Patients (>65 Years) and Non-Small Cell Lung Cancer, run by Kong Fanming at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fanming Kong, PhD (+86 22 27986525, kongfanming08@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.