A Clinical Study of Aliya™ Pulsed Electric Fields (PEF) Delivered Prior to Standard of Care Treatment for Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 9
- 主要终点
- Device and Procedure related serious adverse events
研究概览
简要总结
The goal of this clinical trial is to evaluate safety of delivering Aliya PEF in patients with metastatic cancer within the lungs or stage IV non-small cell lung cancer (NSCLC) who are treatment-naïve and indicated for first-line standard of care (SOC) cancer therapy.
详细描述
The Aliya Treatment System is designed to deliver therapeutic PEF energy to target tissues, via either a percutaneous or bronchoscopic approach. In order to evaluate the therapeutic potential of PEF delivered via the Aliya Treatment System as an interventional treatment, this clinical trial will evaluate the safety of delivering Aliya PEF in non-surgical advanced stage disease treatment-naïve patients indicated for diagnostic biopsy and first line (1L) standard of care (SOC) therapy. Additionally, this study will examine the safety of adding PEF treatment to the care pathway for patients with metastatic cancer to the lung or stage IV NSCLC and further assess the potential immune modulation and treatment effect of PEF for providing benefit to oncological patients, as outlined below.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient has suspected or confirmed metastatic cancer within the lungs, or stage IV non-small cell lung cancer (NSCLC) requiring biopsy.
- •Patient has radiologically documented suspected, or confirmed tumor(s) that are ≤ 5 cm in longest diameter and deemed by the investigator to be suitable per study procedural guidelines for treatment with PEF.
- •Patient is deemed eligible to receive 1L SOC therapy for their malignancy.
- •In the opinion of the investigator, the patient is not a surgical candidate for curative intent, or the patient has refused surgery.
- •Life expectancy ≥ 6 months.
排除标准
- •Patient has received any prior cancer therapy for current tumor(s) to be treated with PEF.
- •Patient is scheduled to receive investigational therapies (including device-based therapy) that may interfere with the study endpoints while on this study.
- •Patient has clinical evidence of leptomeningeal disease or brain metastases that require SOC treatment within 4 weeks post-PEF treatment.
- •Patient with active, known, or suspected autoimmune disease.
- •Patient with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- •Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- •Patient has received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 30 days prior to study enrollment. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.
- •Patient has any history of primary immunodeficiency.
- •Patient has clinical signs or symptoms of active tuberculosis infection.
- •Patient has documented evidence of acute hepatitis or has an active or uncontrolled infection.
- •Patient has undergone major surgery (excluding placement of vascular access) within 28 days prior to study enrollment or has planned major surgeries while enrolled in the study,
- •Other protocol defined inclusion/exclusion criteria apply
结局指标
主要结局
Device and Procedure related serious adverse events
时间窗: 30 days post PEF
The rate of study device-related and/or PEF procedure-related serious adverse events (SAEs)
Percentage of subjects whose SOC cancer treatment was not cancelled or postponed
时间窗: 1 year Post PEF
The percentage of subjects whose SOC cancer treatment was not cancelled or postponed due to a PEF device- or procedure-related AE
次要结局
- Procedural success(Day of procedure)
- Anesthesia Type Usage(During PEF procedure)
- PEF Target Location(During PEF procedure)
- Initiation of first-line (1L) SOC therapy following PEF treatment(12 months)