Table 1 Patient Inclusion and Exclusion Criteria
Key Inclusion Criteria | |
Randomized Controlled Multicenter Study ● Signed and dated informed consent form. ● 18 years of age and older. ● Diagnosis of unresectable Stage 3 pancreatic adenocarcinoma cancer cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria. ● 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 ≤3.5 cm, after receiving three months of treatment with the mFOLFIRINOX regimen. ● Has received 3 months of treatment with the mFOLFIRINOX regimen. ● Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. ● Has an American Society of Anesthesiologists (ASA) classification of physical health status of 1, 2, 3 or 4. | Multicenter Registry ● Signed and dated informed consent form ● 18 years of age and older ● Diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria. ● 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 ≤3.5 cm after standard of care. ● Has received 3 months of standard of care per each participating institution’s guidelines ● Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. ● Has an American Society of Anesthesiologists (ASA) classification of physical health status of 1, 2, 3 or 4. ● Are at an IRE site and are deemed eligible for IRE and receive ablation using the NanoKnife System. ● Shows no evidence of disease progression based on NCCN guidelines after completing 3 months of standard of care. |
Key Exclusion Criteria | |
Randomized Controlled Multicenter Study ● Subjects who are or may be pregnant as determined by a positive pregnancy test or breastfeeding 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. ● Unable to tolerate general anesthetic with full skeletal muscle blockade. ● Is actively bleeding, anticoagulated, coagulopathy, or has any of the following hematology results: hemoglobin less than10 g/dL without the support of growth factors or transfusions; absolute neutrophil count less than 1500 cells/mL; or platelet count less than 100,000. ● Has an implanted cardiac pacemaker, defibrillator, electronic device(s) or implanted device(s) with metal parts in the thoracic cavity at the time of IRE. ● Has a history of epilepsy or other neurological diseases. ● Has renal, cardiac, liver, or hematological abnormalities of concern to the investigator. ● Has Stage 3, 4, or 5 chronic kidney disease. ● Is receiving IRE for margin accentuation. ● Has evidence of disease progression at 3 months after FOLFIRINOX treatment. ● Participating in an interventional trial for pancreatic cancer during the study data collection period. ● Did not meet study defined criteria for adequacy of induction treatment at the end of the 3 months. | Multicenter Registry ● Participating 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 ● Unable to tolerate general anesthetic with full skeletal muscle blockade. ● Has an implanted cardiac pacemaker, defibrillator, electronic device(s) or implanted device(s) with metal parts in the thoracic cavity at the time of IRE. |