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
Metastatic or locally advanced (i.e. unresectable) pancreatic cancer.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137).
Has received prior systemic anti-cancer therapy including investigational agents for pancreatic cancer.
Has received prior radiotherapy within 2 weeks of start of study intervention.
Amsterdam UMC, location VUmc
Lead sponsor
Maastricht University Medical Center
Collaborator
Erasmus Medical Center
Collaborator
St. Antonius Hospital
Collaborator