Observation on the Clinical Efficacy of Electroacupuncture Combined With Immune Checkpoint Inhibitors as Adjuvant Therapy After Surgery for Early-stage Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 405
- 试验地点
- 1
- 主要终点
- Disease free survival(DFS)
研究概览
简要总结
Postoperative immunoadjuvant therapy has been proven to significantly reduce the risk of recurrence after resectable NSCLC, and has become a new standard of postoperative adjuvant therapy for stage II-III NSCLC. Immunotherapy faces challenges such as immune resistance, heterogeneity of biomarker expression, and limitation of immune-suitable population. How to reduce the rate of recurrence and metastasis after surgery, enhance the therapeutic effect of immunotherapy, and then prolong the survival period and improve the quality of life, has become an urgent problem facing the current clinical. Based on the standards of evidence-based medicine, this study for the first time carried out a large sample, multi-center, randomized parallel controlled clinical study to obtain high-quality clinical evidence of the effectiveness and safety of electro-acupuncture and Zilongjin tablet synergic treatment, and formed a standard treatment plan of traditional Chinese medicine.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Non-tumor patients with stage Ⅱ, ⅢA, ⅢB (N2) non-small cell lung cancer diagnosed by pathology or cytology after surgery; (2) driver mutations negative patients; (3) Postoperative adjuvant chemotherapy was received for 1 to 4 cycles;(4)conforms to two qi syndrome of traditional Chinese medicine syndrome differentiation diagnosis of patients; (5) aged 18 to 80 years old; (6) expected lifetime > 6 months; (7) ECOG 0 to 2 points; (8) patients willing to accept this solution treatment, adherence to the good.
排除标准
- •(1) Patients with other malignant tumors in the past or at the same time within 5 years; (2) has a serious heart, liver and kidney damage, or other serious complications; (3) the R1, R2, need after resection, postoperative adjuvant radiotherapy patients; (4) with mental disorders; (5) has a variety of drug allergy, allergic constitution; (6) in pregnancy or lactation women.
研究组 & 干预措施
Immunotherapy
干预措施: Immunotherapy (Drug)
Electroacupuncture combined with immunotherapy
干预措施: Electroacupuncture combined with immunotherapy (Other)
Zilongjin tablet combined with immunotherapy
干预措施: Zilongjin tablet combined with immunotherapy (Drug)
结局指标
主要结局
Disease free survival(DFS)
时间窗: 2year
Time from random start to first recurrence or death.
次要结局
- Overall survival(3,5year)
- DFS(3year)
- EORTC QLQ-C30 Scale(0,2,3,6 month)
- Immune function(0,3 month)
- Lung cancer TCM syndrome score(0,2,3,6 month)
研究者
Kong Fanming
Director of Oncology Department
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine