Actively Recruiting
Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer
Led by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Updated on 2025-07-24
240
Participants Needed
3
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will be an evaluation of the efficacy and safety of acupuncture to enhance the response rate of immunotherapy in advanced lung cancer. The main questions it aims to answer are 1. Does acupuncture heighten the response rate of immunotherapy in advanced lung cancer? 2. Does acupuncture heighten the safety of immunotherapy in advanced lung cancer? Researchers will compare acupuncture to sham acupuncture to see if acupuncture could enhance the response rate of immunotherapy in advanced lung cancer. Both groups will receive a standard anti-tumor Western medical treatment regimen (PD-1/PD-L1 inhibitor combined with chemotherapy), and the experimental and control groups will be treated with 4 cycles of acupuncture or sham-acupuncture on top of the anti-tumor treatment regimen, respectively. Patients were followed up every three weeks for the first three months and every three months thereafter to record any disease progression, adverse events, survival or mortality status, and so on.
CONDITIONS
Official Title
Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years
- ECOG/PS score of grade 0-1 and expected survival of 3 months or more
- Non-small cell lung cancer stage IIIB-IV or small cell lung cancer extensive stage
- PD-L1 tumor cell positive proportion score less than 50%
- Non-small cell lung cancer adenocarcinoma patients without specific gene mutations (EGFR, ALK, ROS1, BRAF, NTRK, RET, MET14 skipping, or amplified gene-driven mutations)
- No previous systemic therapy; first-line treatment only
- Suitable for chemotherapy combined with immunotherapy
- Traditional Chinese Medicine diagnosis of Qi Depression
- At least one measurable tumor lesion larger than 1 cm or lymph node short diameter 1.5 cm or more
- Signed informed consent and voluntary participation
You will not qualify if you...
- Presence of other primary malignant tumors
- Contraindications to immunotherapy
- Autoimmune diseases or need for long-term systemic steroids or immunosuppressants
- Serious and uncontrolled primary diseases of heart, cerebrovascular, liver, kidney, or hematopoietic system
- Metal allergy or severe fear of needles
- Pregnant or breastfeeding
- Unable to cooperate due to mental disorder, intellectual, or language impairment
- Active severe infectious or inflammatory diseases
- Received acupuncture or participated in other clinical trials within 1 month before randomization
- Any medical condition that may risk safety or interfere with study completion as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Actively Recruiting
2
Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
3
Hunan Provincial Integrated Traditional Chinese and Western Medicine Hospital
Changsha, Hunan, China, 410006
Actively Recruiting
Research Team
J
Jiarong FAN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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