Chemotherapy and Irreversible Electroporation (IRE) in the Treatment of Advanced Pancreatic Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)
研究概览
简要总结
Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or gemcitabine in patients with locally advanced pancreatic cancer.
详细描述
Phase II study in which all patients undergoing IRE for the treatment of locally advanced pancreatic carcinoma will receive either FOLFIRINOX or gemcitabine as peri-ablation treatment.
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
- •greater than or equal to 18 years of age
- •diagnosed with stage III pancreatic cancer
- •tumor is measurable
- •GFR > mL/min/1.73m2
- •willing and able to comply with protocol requirements
- •AST/ALT >3 times upper limit of normal
- •stable surgical post-operative course as defined by operative surgeon
排除标准
- •participating in another clinical trial for the treatment of cancer at the time of screening
- •pregnant or currently breast feeding
- •have a cardiac pacemaker or ICD implanted that cannot be deactivated during IRE 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
Treatment
Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE)
干预措施: Irreversible Electroporation (IRE) (Procedure)
Treatment
Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE)
干预措施: Gemcitabine (Drug)
Treatment
Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE)
干预措施: FOLFIRINOX (Drug)
结局指标
主要结局
Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)
时间窗: Time from first dose until subject has reached 90 days post last active study treatment
Adverse and Serious Adverse events will be collected and analyzed
次要结局
- Progression free survival(Time from first dose date to first date of confirmed disease progression, assessed for 90 days)
研究者
Robert C. Martin
Principal Investigator
University of Louisville