A Prospective Open-Label Randomized Study of Traditional Chinese Medicine Combined With Thermal and Cold Ablation for Early-stage Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
Lung cancer is the leading cause of cancer related mortality. At present, surgical treatment is the main choice for early-stage lung cancer. Even after surgery, the 5-year recurrence rate is still as high as 18.4%-24%. Traditional Chinese medicine combined with thermal and cold ablation could be an alternative treatment. Small sample clinical cases verified that this therapy could be an efficacy and safe treatment in a short period. The primary aim of this trial is to evaluate the efficacy of traditional Chinese medicine combined with thermal and cold ablation for patients with stage I non-small cell lung cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient can understand and voluntarily join the study, sign the informed consent form, and the compliance is good.
- •Patients with lung nodule.
- •Maximum diameter of lung nodule ≥8mm.
- •The pathology of lung nodules biopsy was non-small cell lung cancer.
- •I period according to the eighth edition of the TNM staging period.
- •No mediastinal lymph node metastasis.
- •Eastern Cooperative Oncology Group performance status of 0 to
- •No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
- •Sufficient organ functions.
排除标准
- •Patients with previous use of various hormones, immunosuppression or autoimmune diseases.
- •Women during pregnancy or breast-feeding.
- •Patients with severe heart, lung, kidney disease or other systemic diseases
- •Patients with severe hemorrhagic diseases.
- •Patients with a history of drug abuse or mental illness.
- •Other conditions that the investigator has determined are not suitable for participation in this study
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 2 years after ablation
Response were evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee. BEST RESPONSE from the start of study treatment until the end of treatment were reported. Objective response rate is the sum of CR + PR divided by the total number of patients in each group.
次要结局
- DFS(2 years after ablation)
研究者
Ming Li
senior doctor
Shanghai 10th People's Hospital