The Effects of Neoadjuvant Metformin on Tumour Cell Proliferation and Tumour Progression in Pancreatic Ductal Adenocarcinoma

Inclusion Criteria

• •Age greater than or equal to 18 years on the day of study consent
• •Pathologic diagnosis of PDAC where 2 pre-treatment core biopsy samples are available for analysis. Patients with suspected PDAC without a pathologic diagnosis must undergo confirmatory biopsy under endoscopic ultrasound guidance.
• •Resectable disease based on standard imaging criteria
• •Surgery planned ≥ 2 weeks after study entry
• •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• •Adequate hematologic, renal, and hepatic function as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment:
• •* Total bilirubin \< 1.5 times the upper limit of normal (ULN)
• •* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 times the ULN
• •* Lipase \< 1.5 times the ULN
• •* Serum creatinine \< 1.5 times the ULN
• •* Glomerular filtration rate \> 30 mL/min/1.73 m2 according to the modified diet in renal disease abbreviated formula
• •* International normalized ratio (INR) or prothrombin time (PT; PT-INR) and partial thromboplastin time (PTT) \< 1.5 times the ULN
• •* Platelet count \> 100000 /mm3, hemoglobin (\> 9 g/dL, absolute neutrophil count \> 1500/mm3.
• •Baseline fasting glucose \<13.9 mmol/L
• •No prior chemotherapy or radiotherapy for PDAC
• •Serum lactate levels within normal range assessed within 7 days prior to the initiation of study treatment
• •MRI sub-study:
• •Signed informed consent for the optional MRI substudy
• •No contraindications to MRI