Acupuncture for Enhancing Immunotherapy in Advanced NSCLC：a Pilot Study
NCT ID: NCT06461338
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-08-15
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Acupuncture
Acupuncture for 4 times every 3 weeks (one cycle of ICIs combined with chemotherapy) for 12 weeks (4 cycles of ICIs combined with chemotherapy)
acupuncture
Acupuncture at Neiguan(PC6), Zhongwan (CV12), Guanyuan (CV 4), Baihui (DU20), Yintang (GV29), combined with electro-acupuncture at Zusanli(ST36), and Sanyinjiao (SP-6).
Sham acupuncture
Sham acupuncture for 4 times every 3 weeks (one cycle of ICIs combined with chemotherapy) for 12 weeks (4 cycles of ICIs combined with chemotherapy)
Sham acupuncture
Sham acupuncture at Neiguan(PC6), Zhongwan (CV12), Guanyuan (CV 4), Baihui (DU20), Yintang (GV29), combined with sham electro-acupuncture at Zusanli(ST36), and Sanyinjiao (SP-6).
Interventions
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acupuncture
Acupuncture at Neiguan(PC6), Zhongwan (CV12), Guanyuan (CV 4), Baihui (DU20), Yintang (GV29), combined with electro-acupuncture at Zusanli(ST36), and Sanyinjiao (SP-6).
Sham acupuncture
Sham acupuncture at Neiguan(PC6), Zhongwan (CV12), Guanyuan (CV 4), Baihui (DU20), Yintang (GV29), combined with sham electro-acupuncture at Zusanli(ST36), and Sanyinjiao (SP-6).
Eligibility Criteria
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Inclusion Criteria
2. PD-L1 TPS\<50%
3. EGFR/ALK wild-type
4. Has not received prior systemic treatment for advanced NSCLC. For patients who received preoperative neoadjuvant chemotherapy or postoperative adjuvant chemotherapy or radical chemoradiotherapy, if the disease progresses occurred one six months after the last treatment, they can be enrolled. Patients who received targeted therapy or immunotherapy can not be enrolled.
5. Has a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
6. Age≥18 years
7. Has a life expectancy of at least 3 months
8. Has measurable disease
9. Has adequate organ function
10. Voluntarily enrolled into the study, sign the informed consent form and have good compliance
Exclusion Criteria
2. Expected to receive radiotherapy within the next 4 cycles
3. With a combination of serious primary diseases of the heart, cerebrovascular, hepatic, renal, and hematopoietic systems
4. With dementia, neurological disorders, mental retardation, or language impairment, and pregnant or breastfeeding women
5. Combined autoimmune diseases, hematologic disorders, or long-term use of hormones or immunosuppressive drugs
6. Combined with a primary tumor from other sites
7. Had participated in any other clinical trial within the prior 3 months
8. Has known history of Human Immunodeficiency Virus (HIV) or solid organ transplantation
9. With legal incapacity
10. With skin breakdown at the acupuncture point that interferes with treatment
11. With a pacemaker
12. With a fear of acupuncture
13. Had received acupuncture treatment within 6 weeks
14. Has known active Hepatitis B
15. Has interstitial lung disease or a history of pneumonitis that required oral of IV glucocorticoids to assist with management
16. Has fever (\>38°C) or clinically significant infection within 1 week prior to enrolment
17. Has active tuberculosis or indications of severe or uncontrolled systemic diseases
18. With a bleeding tendency, and receiving thrombolytics or anticoagulants
18 Years
ALL
No
Sponsors
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The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
OTHER
Jiangsu Province Hospital of Traditional Chinese Medicine
OTHER
Guangzhou University of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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Haibo Zhang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial Hospital of Traditional Chinese Medicine
Locations
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The First Affiliated Hospital of Guangzhou University of Chinese Medicine.
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
Jiangsu Provincial Hospital of Chinese Medicine
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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2023YFC3503303
Identifier Type: -
Identifier Source: org_study_id