The Clinical Study of Electromagnetic Navigation Bronchoscopy (ENB) Guided Radiofrequency Ablation (RFA) for the Treatment of Early-stage Peripheral Lung Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Objective response rate（ORR）of participants as assessed by the modified RECIST criteria
研究概览
简要总结
The objective of the study was to evaluate the efficacy and safety of electromagnetic navigation bronchoscopy (ENB) guided radiofrequency ablation (RFA) for the treatment of early-stage peripheral lung cancer.
详细描述
The study is aimed to evaluate the efficacy and safety of ENB guided RFA for the treatment of patients with early-stage non-small cell lung cancer (NSCLC). The study is designed as a single-center prospective trial with one arm. The participating centers are Department of pulmonary medicine and endoscopy, Shanghai Chest Hospital affiliated to Shanghai Jiao Tong University, China. Patients diagnosed with early-stage NSCLC will be enrolled into the study. Fifty patients are expected to be enrolled totally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients discovered with peripheral lung nodules that have demonstrated to be non-small cell lung cancer by pathology with the clinical stage of IA.
- •The tumors are solid or part-solid peripheral lung nodules and the length-diameter of the nodules are more than 10 mm and no more than 30 mm.
- •Patients are unsuitable for surgery assessed by multi-modality treatment and agree to the primary treatment of ablation.
- •Patients have good compliance and sign the informed consent.
排除标准
- •Patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and other indications.
- •Patients have contraindications of general anesthesia.
- •Chest CT suggests that navigation bronchoscopy technology cannot guide treatment equipment to reach the peripheral lung lesion.
- •Chest CT or bronchoscopy shows that the bronchial lumen occlusion or deformation leading to the guided and treatment equipment cannot reach the peripheral lung lesion.
- •There are large blood vessels or important structures adjacent to peripheral lung lesion.
- •Researchers consider the patient do not fit for the study.
结局指标
主要结局
Objective response rate（ORR）of participants as assessed by the modified RECIST criteria
时间窗: Three months after ablation
Objective response rate（ORR） is the proportion of patients with complete responses and partial responses according to the modified RECIST criteria.
次要结局
- Progression-free survival (PFS) of participants(From the time of treatment to the time of disease progression or death with a follow-up period of 3 years)
- Overall survival（OS）of participants(From the time of treatment to the time of the patient death with a follow-up period of 5 years)
研究者
Jiayuan Sun
Director, Endoscopy Department
Shanghai Chest Hospital