Effectiveness of Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer：A Randomized Controlled Clinical Study
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.
• 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.