A Multi-center Study of Electromagnetic Navigation Bronchoscopy (ENB) Guided Microwave Ablation for Early-stage Peripheral Lung Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Objective response rate（ORR）
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 microwave ablation (MWA) for the treatment of early-stage peripheral lung cancer.
详细描述
The study is designed as a multi-center prospective trial with one arm. There will be 5 centers participating the study. Patients diagnosed with early-stage non-small cell lung cancer (NSCLC) that are nonsurgical candidate will be enrolled in the study. Sixty patients are expected to be enrolled in the study. The purpose of the study is to evaluate the efficacy and safety of ENB guided MWA for the treatment of patients with early-stage nonsurgical NSCLC.
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 with peripheral lung nodules demonstrated to be NSCLC by pathology with the clinical stage of IA.
- •The length-diameter of the tumors are more than 8 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）
时间窗: Three months after ablation
Tumor response will be evaluated at 3 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
- Arrival rate of the locatable wire(During the procedure)
- Progression-free survival (PFS)(At least 3 months)
- Overall survival (OS)(From the time of treatment to the time of the patient death with a follow-up period of 5 years)
- Complication rate(From the time of treatment to one month after ablation)
研究者
Jiayuan Sun
Director, Department of Respiratory Endoscopy
Shanghai Chest Hospital