Neoadjuvant mFOLFIRINOX With Perioperative Oral Hydroxychloroquine in Resectable Pancreatic Adenocarcinoma
Status:
Recruiting
Trial end date:
2028-06-01
Target enrollment:
Participant gender:
Summary
This will be a phase I/II trial examining the safety and tolerability of pre-operative
mFOLFIRINOX in combination with peri-operative oral hydroxychloroquine (FHQ) in the treatment
of subjects with adenocarcinoma of the pancreas. Subjects will be staged prior to protocol
entry by contrast-enhanced helical abdominal CT scan done using a pancreas mass protocol or
EUS. Eligible subjects with biopsy-proven, resectable pancreatic adenocarcinoma without
evidence of venous or arterial involvement on CT scan receive HCQ orally in combination with
mFOLFIRINOX prior to surgery. Hydroxychloroquine will begin with the first dose of
mFOLFIRINOX and continue for 2 weeks post-operatively. Three to six weeks after the last dose
of mFOLFIRINOX, patients will undergo surgical exploration and pancreatectomy if technically
feasible and all toxicities have resolved. Pathologic specimens will undergo detailed
histopathologic and immunohistochemical evaluations with particular attention to the six
surgical margins of resection: the bile duct margin (for Whipple specimens), the margin of
pancreatic transection, the retroperitoneal margin, the proximal and distal duodenal margins
(for Whipple specimens), and the portal vein margin along the pancreatic head (for Whipple
specimens) or medial pancreas (for distal pancreatectomies). Tissue specimens will be stored
at -80C for future correlative studies of autophagy and tumor response to protocol therapy.
Ten to fourteen weeks following completion of successful surgical removal of their tumor,
subjects will undergo repeat staging studies per standard of care. Subjects will pursue
standard of care adjuvant therapy options at the discretion of their physician.