Resectable Pancreatic Ductal Adenocarcinoma Clinical Trial
Official title:
The Effects of Neoadjuvant Metformin on Tumour Cell Proliferation and Tumour Progression in Pancreatic Ductal Adenocarcinoma
This is a single arm, non-randomized phase II study of neoadjuvant metformin in resectable
PDAC. Twenty patients will be enrolled and treated with metformin 500 mg BD for a minimum of
7 days, until 2 days prior to surgery. Patients will undergo laboratory investigations at
baseline, prior to surgery and 4-10 weeks after surgery. Patients eligible for and consented
to the optional MRI substudy will undergo diffusion-weighted MRI 1 to 14 days before surgery.
At surgery, resected tumour and normal tissue will be collected and banked. FFPE specimens
will be used for sectioning, histological analysis and IHC for Ki67 (cell proliferation
marker), pAMPK, ACC targets, p53 and mTOR targets, apoptotic markers (Bax, Bcl-2, caspases 3,
8 and 9). Fresh frozen tumour and matched normal tissue samples will be used for western blot
analysis of insulin and IGF receptors, total and activated ERK and Akt, and RNAseq analysis.
Pre-metformin biopsy samples will be retrieved for molecular analysis.
Fasting blood samples at baseline and before surgery will be analyzed for glucose and insulin
levels. Plasma and whole blood will also be processed and banked for circulating tumour DNA
analysis. Urine samples will be sent for metabolomic profiling.
n/a
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