Neoadjuvant Triple Treatment With mFOLFIRINOX, Pembrolizumab and SABR in Patients With (Borderline) Resectable Pancreatic Cancer (PREOPANC-5): a Multicenter Single Arm Phase Ib/II Trial of the Dutch Pancreatic Cancer Group
Since patients with (borderline) resectable pancreatic cancer have a limited life expectancy, it is important to improve treatment strategies. Therefore, the objective of this study is to investigate whether neoadjuvant triple treatment with chemotherapy (mFOLFIRINOX), immunotherapy (pembrolizumab and stereotactic radiotherapy, followed by adjuvant surgery and chemotherapy and immunotherapy, improves survival in patients with (borderline) resectabel pancreatic cancer.
• Histologically or cytologically confirmed adenocarcinoma of the pancreas (WHO VI or VII)
• Male or female participants who are at least 18 years of age on the day of signing informed consent
• Primary resectable or borderline resectable disease (DPCG criteria)
• ECOG performance status 0 or 1
• Ability to undergo surgery, radiotherapy, chemotherapy and immunotherapy
• Leucocytes (WBC) ≥ 3.0 X 10\*9/l, Platelets ≥ 100X 10\*9 /l, Hemoglobin ≥ 6 mmol/l, Renal function: E-GFR \> 50 ml/min, Bilirubin \< 50 µmol/l or planned for biliary drainage
• A male participant must agree to use a contraception as detailed in Appendix 6 of this protocol during the treatment period and for at least 18 weeks after the last dose of study treatment and refrain from donating sperm during this period.
• A female participant is eligible to participate if she is not pregnant (see Appendix 6), not breastfeeding, and at least one of the following conditions applies: Not a:
⁃ woman of childbearing potential (WOCBP) OR WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 18 weeks after the last dose of study treatment Written informed consent