Registry to Evaluate Effectiveness and Safety of the NanoKnife System for the Ablation of Stage 3 Pancreatic Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 532
- 试验地点
- 14
- 主要终点
- Overall Survival
研究概览
简要总结
This multicenter, observational study will evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC). Eligible patients will be recruited over a 36-month period and participating institutions will enroll and provide data on consecutive patients that meet inclusion and exclusion criteria. Each patient will be followed up for the duration of the study or until death. The study will include two (2) cohorts: patients who received standard of care (SOC) and received irreversible electroporation (IRE) [IRE cohort], and patients who were treated with SOC and did not receive IRE [SOC cohort].
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Provisions of signed and dated informed consent form
- •Patient is 18 years of age and older
- •Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria
- •Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery
- •Maximum axial and anterior to posterior tumor dimension of ≤3.5cm after SOC
- •Patient has received 3 months of SOC per each participating institution's guidelines
- •Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1 or
- •Patients at IRE sites who are deemed eligible for IRE and receive ablation using the NanoKnife System
- •Patient shows no evidence of disease progression based on NCCN guidelines after completing three (3) months of SOC
排除标准
- •Participation in an interventional trial for pancreatic cancer during the study data collection period
- •Pregnant or lactating patients or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy
- •Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade
- •Patients with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE
研究组 & 干预措施
IRE Cohort
Patients who received SOC and received IRE
干预措施: NanoKnife System (Device)
IRE Cohort
Patients who received SOC and received IRE
干预措施: SOC (Drug)
SOC Cohort
Patients who received SOC and did not receive IRE
干预措施: SOC (Drug)
结局指标
主要结局
Overall Survival
时间窗: Time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months.
To evaluate the effectiveness of the NanoKnife System when used for the ablation of Stage 3 PC in real world treatment settings, by testing the hypothesis that IRE with the NanoKnife System improves overall survival (OS)
次要结局
未报告次要终点