Effectiveness of Acupuncture Combined With PD-1/PD-L1 Inhibitors for Advanced Lung Cancer：A Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 6
- 主要终点
- Objective Response Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Acupuncture
干预措施: Acupuncture (Device)
sham acupuncture
干预措施: Sham Comparator (Device)
结局指标
主要结局
Objective Response Rate
时间窗: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred
次要结局
- Disease Control Rate(At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred)
- Progression-Free Survival(At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred)
- Overall Survival(At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until death occurred.)
- PHQ-9(At 0,4,7,10,13 weeks,6 months from randomization)
- Insomnia Severity Index(At 0, 4, 7, 10, and 13 weeks and 6 and 9 months from randomization)
- Eastern Cooperative Oncology Group Performance Status, ECOG PS(At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until death occurred)
- Lung Cancer Symptom Scale(At 0,4,7,10,13 weeks,6,9 months from randomization)
- weight(At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression or death occurred)
- adverse event(At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression or death occurred)
- Duration of immunotherapy(At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until immunotherapy is no longer used)
- GAD-7(At 0,4,7,10,13 weeks,6 months from randomization)
研究者
Liu Zhishun
professer，Chief Physician
Guang'anmen Hospital of China Academy of Chinese Medical Sciences