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.
Single group
Pembrolizumab
DrugPembrolizumab 400 mg will be administered as a 30 minute IV infusion every 6 weeks.
Folfirinox
DrugFOLFIRINOX is a combination of systemic chemotherapy agents. FOLFIRINOX consists of oxaliplatin at a dose of 85 mg/m2, given as a 2-hour intravenous infusion, immediately followed by leucovorin at a dose of 400 mg/m2 given as a 2-hour intravenous infusion, with the addition, after 30 minutes, of irinotecan at a dose of 150 mg/m2, given as a 90-minute intravenous infusion through a Y-connector. This treatment is followed by a continuous intravenous infusion of 2400 mg/m2 5-FU over a 46-hour period every 2 weeks. (The FOLFIRINOX given in the trial is the modified scheme, whereby the fluorouracil bolus at a dose of 400 mg/m2 is omitted and the irinotecan dose reduced to 150 mg/m2).
SABR
RadiationSABR will be delivered in an image-guided hypofractionated scheme of 5 fractions of 8 Gy (total 40 Gy), prescribed to 95% of the planning target volume (PTV). Treatment is delivered on five non-consecutive days.
1-year progression-free survival rate
Click on the lead sponsor to view all of their trials.
Amsterdam UMC, location VUmc
Lead sponsor
Maastricht University Medical Center
Collaborator
Erasmus Medical Center
Collaborator
St. Antonius Hospital
Collaborator
