Electromagnetic Navigation Bronchoscopy Guided Ablation Therapy Combined With VATS in the Treatment of Multiple Primary Lung Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of ablation efficacy, ORR (objective response rate)
研究概览
简要总结
The study is designed as a prospective trial whose purpose is to evaluate the effectiveness and safety of ENB-guided ablation therapy combined with VATS in the treatment of multiple primary lung cancers (MPLC).
详细描述
Patients will be first screened, and only after meeting all the selection criteria, not meeting any exclusion criteria, and signing the informed consent, could they be enrolled in the group to receive ENB-guided ablation therapy combined with VATS. The primary endpoint is objective response rate (ORR). The secondary endpoints include progression-free survival (PFS), overall survival (OS) and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Minutes 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •The subject is diagnosed as multiple primary lung cancer via preoperative imaging/pathological examination.
- •Thin-slice CT images show that the ablation Lesion A is accessible/adjacent to bronchi and the size is ≤ 3 cm.
- •The subject with multiple primary lung cancers can be treated with ENB-guided ablation therapy combined with VATS according to multidisciplinary assessment.
排除标准
- •The subject who cannot tolerate general anesthesia for their cardiopulmonary function, or there are other contraindications, such as uncorrectable coagulopathy.
- •The situation in which the investigators think that the subject is not suitable to participate in this study.
结局指标
主要结局
Evaluation of ablation efficacy, ORR (objective response rate)
时间窗: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years.
ORR is defined as the proportion of patients with complete response (CR) and partial response (PR) after ablation therapy. Efficacy evaluation is based on Modifield Response Evaluation Criteria in Solid Tumors (mRECIST).
次要结局
- Evaluation of ablation efficacy, OS (overall survival)(From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.)
- Evaluation of ablation efficacy, PFS (progression-free survival)(From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.)
- Observation of complications of ablation(From date of treatment to the one month after ablation.)
研究者
Jiayuan Sun
Director, Department of Respiratory Endoscopy
Shanghai Chest Hospital