Actively Recruiting
Effectiveness of Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer: A Randomized Controlled Clinical Study
Led by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Updated on 2025-07-24
240
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of acupuncture combined with immunotherapy in people with advanced lung cancer. The study aims to find out if acupuncture can improve how well immunotherapy works and whether it makes the treatment safer. Participants have advanced forms of lung cancer and are treated with a standard Western medical regimen including PD-1/PD-L1 inhibitors combined with chemotherapy.
CONDITIONS
Brief 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 at least 3 months
- Diagnosed with non-small cell lung cancer stage IIIB-IV or extensive-stage small cell lung cancer
- PD-L1 tumor cell proportion score less than 50%
- Non-small cell lung cancer adenocarcinoma patients without certain gene mutations (EGFR, ALK, ROS1, BRAF V600, 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 after basic assessment
- Autoimmune diseases or need for long-term systemic steroids or immunosuppressants
- Serious uncontrolled diseases of the heart, brain vessels, liver, kidney, or blood 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 treatment or participated in other clinical trials within 1 month before randomization
- Any other medical condition or reason judged by the investigator to make participation unsafe or unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Four consecutive treatment cycles
Participants receive a standard anti-tumor treatment regimen including PD-1/PD-L1 inhibitors combined with chemotherapy. Those in the acupuncture group also receive acupuncture treatments, while the sham group receives sham acupuncture. Acupuncture or sham treatments are performed twice by the investigator during days 1 to 5 of each cycle, and then participants or family members perform press needle treatments with remote assistance on days 8 to 13 and 15 to 20 for four consecutive cycles.
Multiple visits for acupuncture treatments during each cycle, including investigator-administered and remotely assisted sessions
Duration - Up to 24 months or until disease progression or death
Participants are monitored for treatment effectiveness and safety through scheduled assessments of tumor response, survival, symptoms, and adverse events.
Visits at 0, 4, 7, 10, 13 weeks and 6, 9, 12, 15, 18, 21, 24 months from randomization
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
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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