A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
Subjects will be offered the opportunity to participate in a randomized, controlled, 2-arm,
unblinded multicenter trial (RCT). There will be 2 study arms: the control arm receiving
chemotherapy with the modified FOLFIRINOX regimen alone; and the irreversible electroporation
(IRE) arm, receiving chemotherapy with the modified FOLFIRINOX regimen followed by IRE with
the NanoKnife System using either an open or a percutaneous approach. All subjects will be
treated with the modified FOLFIRINOX regimen for at least 3 months; randomization to either
control or IRE arm will take place at the time of completion of the 3 month modified
FOLFIRINOX chemotherapy regimen. Randomization will be conducted centrally. Subjects will be
randomized in a 1:1 ratio and must be found to have no evidence of disease progression after
completion of the 3 month modified FOLFIRINOX chemotherapy regimen in order to participate in
the RCT. All radiologic assessments will be performed as consistent with the imaging
protocol. All post induction and post IRE treatments are left to the discretion of the
treating physician. The minimum period of follow-up will be for 24 months or until death.