Lung Cancer (NSCLC)NCT07076836
Zusanli (ST36) Electroacupuncture Treatment for Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer
A study testing Acupuncture in people with Lung Cancer (NSCLC) and Immune Checkpoint Blockade, run by West China Hospital at 1 site in China.
Trial summary
This study aims to investigate the potential synergistic effects of acupuncture combined with immune checkpoint inhibitors in cancer therapy. Over the past decade, significant progress in cancer immunotherapy has been driven by breakthroughs in understanding immune checkpoint molecules; however, monotherapy with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer (NSCLC), Immune Checkpoint Blockade, Electroacupuncture
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2026to 30 Jun 2028
- Phase
- Interventional
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤80 years at the time of written informed consent, of either sex;
- Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) receiving neoadjuvant immunotherapy;
- Undergoing standard neoadjuvant treatment with chemotherapy plus immunotherapy
- ECOG performance status score of 0-2;
- Life expectancy >3 months;
- At least one measurable target lesion per RECIST 1.1 criteria:
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- Tumor lesions with a long axis ≥10 mm on CT scan (slice thickness ≤5 mm);
- Lymph node lesions with a short axis ≥10 mm on CT scan;
- Previously irradiated or locally treated lesions may be designated as target lesions if documented tumor progression post-treatment.
- Adequate major organ function within 14 days prior to randomization, defined by the following laboratory parameters without blood transfusions, growth factors, albumin, or blood products:
- Hematological tests: Hemoglobin ≥80 g/L; Absolute neutrophil count >1.5×10⁹/L; Platelet count ≥90×10⁹/L;
- Biochemical tests: Total bilirubin ≤1.5×ULN (upper limit of normal); ALT/AST ≤2.5×ULN; Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (Cockcroft-Gault formula);
- Coagulation tests: Prothrombin time (PT) and INR ≤1.5×ULN (unless on warfarin anticoagulation);
- Cardiac evaluation: Left ventricular ejection fraction (LVEF) ≥50% by Doppler echocardiography.
- Voluntary participation with signed informed consent, good compliance, and willingness of the patient and their family to cooperate with survival follow-up.
Who cannot join
- Pregnant participants;
- Post-organ transplant patients;
- Patients with uncontrolled diabetes mellitus, severe cardiac, central nervous system, psychiatric disorders, or coagulopathy;
- Patients with severe malnutrition;
- Patients with implanted cardiac pacemakers;
- Patients with bleeding disorders;
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- Patients with a history of severe allergies or anaphylaxis;
- Patients with skin infections, lesions, ulcers, or scars at the ST36 (Zusanli) acupoint site;
- Patients with metal allergy, severe needle phobia, or intolerance to electroacupuncture therapy.
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
West China Hospital
Chengdu, Sichuan, 610041
Nan Lin, +86 18708305692, sculinnan@qq.com
About this study
This study aims to investigate the potential synergistic effects of acupuncture combined with immune checkpoint inhibitors in cancer therapy. Over the past decade, significant progress in cancer immunotherapy has been driven by breakthroughs in understanding immune checkpoint molecules; however, monotherapy with immune checkpoint inhibitors still faces challenges due to low response rates. As a traditional Chinese medical intervention, acupuncture modulates neuro-immune pathways to achieve remote regulation of organ functions, with particular anti-tumor potential observed at the Zusanli (ST36) acupoint-a site located 2 cm below the knee that can be stimulated via electroacupuncture (EA) to improve gastrointestinal function and alleviate inflammation. Preclinical evidence demonstrates that EA suppresses tumor growth in breast cancer models, reduces levels of pro-inflammatory cytokines such as IL-1β and TNF-α, enhances anti-tumor activity of CD8+ T cells and NK cells, and decreases accumulation of immunosuppressive myeloid-derived suppressor cells (MDSCs). Animal studies show that ST36 EA increases key immunomodulatory factors like serum IFN-γ, IL-2, and IL-17, thereby potentiating the efficacy of anti-tumor drugs. Guided by the traditional TCM principle of "reinforcing healthy qi to consolidate the body's resistance," modern clinical applications of EA combined with specific acupoint regimens (e.g., ST36, Sanyinjiao) have effectively alleviated cancer-related pain, chemotherapy-induced side effects, and fatigue. This study will evaluate the safety and immunosensitization effects of ST36 EA combined with PD-1 inhibitors in non-small cell lung cancer patients, employing 1 mA electroacupuncture for 3 consecutive days to activate immune responses. By leveraging acupuncture-induced immune remodeling, this approach aims to provide a novel integrative medicine strategy to overcome resistance to immunotherapy.
Read the detailed description
This study aims to investigate the potential synergistic effects of acupuncture combined with immune checkpoint inhibitors in cancer therapy. Over the past decade, significant progress in cancer immunotherapy has been driven by breakthroughs in understanding immune checkpoint molecules; however, monotherapy with immune checkpoint inhibitors still faces challenges due to low response rates. As a traditional Chinese medical intervention, acupuncture modulates neuro-immune pathways to achieve remote regulation of organ functions, with particular anti-tumor potential observed at the Zusanli (ST36) acupoint-a site located 2 cm below the knee that can be stimulated via electroacupuncture (EA) to improve gastrointestinal function and alleviate inflammation. Preclinical evidence demonstrates that EA suppresses tumor growth in breast cancer models, reduces levels of pro-inflammatory cytokines such as IL-1β and TNF-α, enhances anti-tumor activity of CD8+ T cells and NK cells, and decreases accumulation of immunosuppressive myeloid-derived suppressor cells (MDSCs). Animal studies show that ST36 EA increases key immunomodulatory factors like serum IFN-γ, IL-2, and IL-17, thereby potentiating the efficacy of anti-tumor drugs. Guided by the traditional TCM principle of "reinforcing healthy qi to consolidate the body's resistance," modern clinical applications of EA combined with specific acupoint regimens (e.g., ST36, Sanyinjiao) have effectively alleviated cancer-related pain, chemotherapy-induced side effects, and fatigue. This study will evaluate the safety and immunosensitization effects of ST36 EA combined with PD-1 inhibitors in non-small cell lung cancer patients, employing electroacupuncture during immune therapy and chemotherapy for immune responses. By leveraging acupuncture-induced immune remodeling, this approach aims to provide a novel integrative medicine strategy to overcome resistance to immunotherapy.
- Being tested
- Acupuncture, sham acupuncture
- Keywords
- lung cancer (NSCLC), immune checkpoint blockade, electroacupuncture
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Also called ICIs, chemotherapy
The electroacupuncture parameters were set as follows: frequency at 10 Hz, current intensity at 0.5 mA, pulse width at 50 μs, and each session lasted 30 minutes. On the first day of chemotherapy, electroacupuncture was administered 1-2 hours prior to chemotherapy initiation. From Day 2 to the final day of chemotherapy, electroacupuncture sessions were conducted daily between 2:00 PM and 4:00 PM.
sham acupunctureDevice
Also called ICIs
The sham electroacupuncture group referenced the same acupoints as the electroacupuncture group, but the false acupoint shallow needling method and false electrode method are used, and the treatment time and course are the same as the electroacupuncture group.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture group | Experimental | Not described Receives: Device: Acupuncture |
| Sham electroacupuncture group | Experimental | Not described Receives: Device: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neoadjuvant Immunotherapy Conversion Rate
Measured: Baseline, After neoadjuvant immunotherapy (2-3 cycle, about 2 months after baseline)
Secondary outcomes (2)
Peripheral blood immune cell alterations
Peripheral blood immune cell alterations assessed by flow cytometry: CD4+/CD8+ T-cell ratio, Tregs, and NK cell subsets
Measured: Baseline (Day 1), end of Cycle 1 (21 days), Cycle 2 (42 days), and Cycle 3 (63 days). Each immunotherapy cycle is 21 days
Serum and Urine dopamine pathway and metabolites
Serum norepinephrine and epinephrine concentrations analyzed via mass spectrometry
Measured: Baseline (Day 1), end of Cycle 1 (21 days), Cycle 2 (42 days), and Cycle 3 (63 days). Each immunotherapy cycle is 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start31 Aug 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuelei Ma MD, West China Hospital
- Investigators
- Xuelei Ma, MD, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076836
- Sponsor's protocol ID
- Approval No. 2030 (2023)
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes