About this trial
The purpose of this study is to evaluate the short and intermediate term safety of the NanoKnife Irreversible Electroporation System when used off-label to treat unresectable pancreatic cancer. In addition, the study will evaluate the efficacy of this device in treating pain associated with unresectable pancreatic cancer. Quality of life post-procedure will also be collected.
Eligibility criteria
Qualifiers
> = 18 years of age
Must be found to have locally advanced unresectable disease following standard chemotherapy ± radiotherapy as demonstrated with either CT/MRI imaging and surgical evaluation, and not have taken any chemotherapy/radiotherapy within 5 weeks of treatment with the NanoKnife IRE System
Must have an INR < 1.5
Are willing and able to comply with the protocol requirements
Disqualifiers
Creatinine > 2.0 mg/dL
Any lab value with a grade 3 or 4 toxicity as defined by the CTCAE Version 5.0
Inability to stop antiplatelet and coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife System
Tumor size not measurable
Trial design
Treatments tested in this trial
- NanoKnife