Status:
RECRUITING
Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions:
Lung Cancers
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 acupu...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age 18-75 years;
- ECOG/PS score of grade 0-1 and expected survival ≥ 3 months;
- Non-small cell lung cancer AJCC lung cancer staging of stage IIIB-IV, or small cell lung cancer staging of extensive stage;
- PD-L1 immunohistochemistry detection of tumor cell positive proportion score (TPS) \<50%;
- Non-small cell lung cancer adenocarcinoma patients do not have EGFR-sensitive mutations, ALK fusions, ROS1 fusions, BRAFV600 mutations, NTRK fusions, RET fusions, MET14 skipping mutations, and amplified gene-driven mutations by genetic testing;
- Patients with no previous systemic therapy/first-line treatment;
- Patients suitable for chemotherapy combined with immunotherapy;
- Traditional Chinese Medicine (TCM) diagnosis of Qi Depression;
- Having at least 1 measurable tumor lesion (diameter \> 1cm) or lymph node short diameter ≥ 1.5cm;
- Sign the informed consent form and voluntarily participate in this study.
- Exclusion criteria:
- Combined with other primary malignant tumors;
- Those who have contraindications to immunotherapy after basic assessment of immunotherapy;
- Those with autoimmune diseases or those who need long-term treatment with systemic steroids or immunosuppressants;
- Those with combined serious and uncontrolled primary diseases of heart, cerebrovascular, liver, kidney, hematopoietic system and so on;
- Those with metal allergy or severe fear of needles;
- Those who are pregnant or breastfeeding;
- Those who are unable to cooperate to complete the assessment due to mental disorder, intellectual or language impairment;
- Those with active severe infectious or inflammatory diseases;
- Those who have received acupuncture treatment or other clinical trials within 1 month prior to randomization;
- In the judgment of the investigator, persons who have a concomitant medical condition that seriously jeopardizes the safety of the participant or interferes with the completion of the study, or who are deemed to have other reasons for not being suitable for enrollment.
Exclusion
Key Trial Info
Start Date :
June 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06926140
Start Date
June 21 2025
End Date
July 31 2028
Last Update
July 24 2025
Active Locations (3)
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1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
2
Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine
Beijing, Beijing Municipality, China, 100053
3
Hunan Provincial Integrated Traditional Chinese and Western Medicine Hospital
Changsha, Hunan, China, 410006