Neoadjuvant Triple Treatment with FOLFIRINOX Plus Pembrolizumab and SABR in Patients with Borderline Resectable Pancreatic Cancer (PREOPANC-5): a Multicenter Single Arm Phase I/II Trial of the Dutch Pancreatic Cancer Group
Since patients with borderline resectable pancreatic cancer (BRPC) 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 chemotherapy, immunotherapy and radiotherapy, followed by surgery and chemotherapy and immunotherapy survival in patients with BRPC.
• Histologically or cytologically confirmed pancreatic cancer
• Male or female participants who are at least 18 years of age on the day of signing in-formed consent
• Borderline resectable tumor (see table 1 for definitions of resectability)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Ability to undergo surgery, radiotherapy and chemotherapy
• Leucocytes (WBC) ≥ 3.0 X 109/l
• Platelets ≥ 100X 109 /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 5 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 5), not breastfeeding, or a woman of childbearing potential (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