Prospective Clinical Study of Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,753
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
Lung cancer is the leading cause of cancer related mortality. Among them, non small cell lung cancer accounts for 85%. Only part of patients could be treated with radical surgery. Mitochondria-targeted system therapy combined with radiofrequency 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 determine if the efficacy of mitochondria-targeted system therapy combined with radiofrequency ablation is comparable to that of standard surgical interventions for patients with non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 85 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 single nodule.
- •Before IIB period according to the eighth edition of the TNM staging period.
- •No mediastinal lymph node metastasis.
- •No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
- •Eastern Cooperative Oncology Group performance status of 0 to 1
- •Sufficient organ functions
排除标准
- •Active bacterial or fungous infection.
- •Simultaneous or metachronous (within the past 5 years) double cancers.
- •Patients with contraindications to radiofrequency ablation and inability to complete treatment;
- •Women during pregnancy or breast-feeding.
- •Uncontrollable diabetes mellitus.
- •Patients with severe heart, lung, kidney disease or other systemic diseases who have been judged to have a severe impact on survival or who are pre-assessed to be unable to tolerate thoracoscopic surgery
研究组 & 干预措施
Mitochondrial therapy with radiofrequency ablation
干预措施: Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation (Other)
Surgery
干预措施: Surgery (Procedure)
结局指标
主要结局
Disease-free survival
时间窗: From the date of randomization until the date of first documented progression，assessed up to 60 months
次要结局
- Overall survival(From the date of randomization until the date of death from any cause，assessed up to 60 months)
研究者
Ming Li
Associate senior doctor
Shanghai 10th People's Hospital