Bronchoscopic Cryo-Immunotherapy of Lung Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Experience Pneumothorax Requiring Tube Thoracostomy
研究概览
简要总结
This is a safety and feasibility study of bronchoscopic cryo-immunotherapy (BCI) of peripheral lung tumors in advanced non-small cell lung cancer for the intention of inducing anti-tumor immune responses. The sample size for this study will be 15 patients. Pre- and post- BCI peripheral blood samples will be analyzed to assess for anti-tumor immune responses. Post-BCI peripheral blood will be collected 7 and 14 days after the procedure.
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
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peripheral lung tumor on pre-procedure chest CT scan, which is known or suspected to be advanced, inoperable non-small cell lung cancer (stages IIIA/B/C and IVA/B) based on the 8th edition TNM staging guidelines
- •Pre-procedure chest CT scan with the presence of a bronchus or airway path leading directly to the peripheral lung tumor (also known as a "bronchus sign")
- •Undergoing bronchoscopy for diagnostic and/or palliative purpose unrelated to this study.
- •Documentation of non-small cell lung cancer either prior to procedure or via on-site pathology review during bronchoscopy (prior to proceeding with planned BCI)
- •Ability to provide informed consent
- •Concomitant chemotherapy, immunotherapy, and/or radiation therapy are allowed
- •ECOG performance status less than or equal to 2
排除标准
- •Pregnancy
- •Currently on a platelet inhibitor (such as Clopidogrel) other than aspirin or NSAIDS, or on a blood thinner (such as heparin, enoxaparin, or a novel oral anticoagulant), which is unable to be held for planned bronchoscopy
- •INR >= 1.5 (post correction)
- •Platelets =< 100,000 (post correction)
- •Bleeding diathesis
- •Contraindication to bronchoscopy
- •Absence of tissue diagnosis of non-small cell lung cancer either prior to procedure or during on-site pathology review at time of bronchoscopy.
结局指标
主要结局
Percentage of Participants Who Experience Pneumothorax Requiring Tube Thoracostomy
时间窗: Up to Day 7 Post-BCI
Length of Time to Perform BCI
时间窗: Day 0
Length of Fluoroscopy Exposure During BCI
时间窗: Day 0
Percentage of Successful Performances Among Patients in Whom BCI is Attempted
时间窗: Day 0 (Intraoperative)
Success is defined as identification of the target peripheral lung tumor by radial endobronchial ultrasound within 20 minutes followed by completed cryoablation of target tumor.
Percentage of Patients Who Experience Bleeding Complications
时间窗: Up to Day 7 Post-BCI
Percentage of Participants Who Experience Grade 4-5 Adverse Events Potentially Related to Procedure
时间窗: Up to Day 7 Post-BCI
Incidence of National Cancer Institute Common Terminology Criteria for Adverse Events Grade 4 or 5 adverse events that may be possibly, probably, or definitely related to BCI.
次要结局
- Percentage of Patients With Peripheral Blood CD8+ T Cells Displaying at Least One Combination of Hypothesized Markers(Up to Day 14 Post-BCI)