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Trial Title:
Acupuncture for Enhancing Immunotherapy in Advanced NSCLC：a Pilot Study
NCT ID:
NCT06461338
Condition:
Non-small Cell Lung Cancer
Non-Small-Cell Lung Carcinoma
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Non-Small Cell Lung Cancer
Acupuncture
Immune Checkpoint Inhibitors
Effect
Safety
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
acupuncture
Description:
Acupuncture at Neiguan(PC6), Zhongwan (CV12), Guanyuan (CV 4), Baihui (DU20), Yintang
(GV29), combined with electro-acupuncture at Zusanli(ST36), and Sanyinjiao (SP-6).
Arm group label:
Acupuncture
Intervention type:
Procedure
Intervention name:
Sham acupuncture
Description:
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).
Arm group label:
Sham acupuncture
Summary:
This multicentre, randomized controlled trial evaluates the effect and safety of
integrating acupuncture with immunotherapeutic sensitization in treating NSCLC.
Participants will be randomly assigned to undergo either acupuncture or sham acupuncture
concurrent with the initial four cycles of standard ICIs combined with chemotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Has a histologically-confirmed or cytologically confirmed diagnosis of stage IIIB or
IV NSCLC.
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:
1. Unable to complete baseline assessments
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Guangzhou University of Chinese Medicine.
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Contact:
Last name:
Hanrui Chen, Prof.
Facility:
Name:
Guangdong Provincial Hospital of Chinese Medicine
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Contact:
Last name:
Yanjuan Zhu, Prof.
Phone:
86 20 81887233
Phone ext:
34830
Email:
zyjsophy@gzucm.edu.cn
Contact backup:
Last name:
Xuesong Chang, Prof.
Phone:
86 20 81887233
Phone ext:
34830
Email:
xuesongch2019@.gzucm.edu.cn
Facility:
Name:
Jiangsu Provincial Hospital of Chinese Medicine
Address:
City:
Nanjing
Zip:
210000
Country:
China
Contact:
Last name:
Peng Shu, Prof.
Start date:
August 2024
Completion date:
September 2026
Lead sponsor:
Agency:
Guangzhou University of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Jiangsu Province Hospital of Traditional Chinese Medicine
Agency class:
Other
Source:
Guangzhou University of Traditional Chinese Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06461338
