Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment
研究概览
简要总结
Compare the efficacy and tolerability of irreversible electroporation in combination with Nivolumab in patients with locally advanced pancreatic cancer.
详细描述
Immunotherapy and irreversible electroporation in the treatment of advanced pancreatic adenocarcinoma. This is a Phase II study in which all patients undergoing irreversible electroporation of locally advanced pancreatic adenocarcinoma will be treated with nivolumab post-operatively.
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
- •≥ 18 years if age
- •Diagnosed with stage III pancreatic cancer
- •Tumor is measurable
- •Glomerular Filtration Rate > 60 m/L/min/1.73 m(2)
- •Willing and able to comply with the protocol requirements
- •Able to comprehend and have signed the informed consent to participate
排除标准
- •Participating in another clinical trial for the treatment of cancer at time of screening
- •Are pregnant or currently breast feeding
- •Have a cardiac pacemaker or Implantable Cardioverter Defibrillator implanted that cannot be deactivated during the procedure
- •Have non-removable implants with metal parts within 1 cm of the target lesion
- •Had a myocardial infarction within 3 months prior to enrollment
研究组 & 干预措施
Single Arm
All patients undergoing irreversible electroporation will be treated with nivolumab
干预措施: Nivolumab (Drug)
Single Arm
All patients undergoing irreversible electroporation will be treated with nivolumab
干预措施: Irreversible Electroporation (Procedure)
结局指标
主要结局
Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment
时间窗: Baseline thru 100 days after receiving last dose
Adverse events and Serious adverse events will be collected
次要结局
- Progression Free Survival(Every three months for 4 years.)
- Overall Survival(Every three months for 4 years.)
研究者
Robert C. Martin
Principal Investigator
University of Louisville