Using Tumour DNA and Proteins to Better Understand How Pancreatic Cancer Responds to Treatment

Inclusion criteria

Participants must meet all of the following criteria prior to Pre-Baseline registration:

• Age 18 years or older.
• Histological or radiological diagnosis of resectable, borderline resectable, or locally advanced PDAC.
• Medically fit and planned to undergo laparoscopic procedure as part of standard of care.
• Able to give informed consent for the study-related procedures performed during laparoscopy.

Participants must meet all of the following criteria to be eligible for enrollment in the Main Study:

• Age 18 years or older.
• Enrolled in the Personalized Oncogenomics (POG) Program at BC Cancer.
• Histological and/or radiological diagnosis of resectable, borderline resectable, or locally advanced PDAC. Participants without a histological diagnosis of PDAC must undergo confirmatory histological diagnosis prior to treatment start date.
• Medically fit to undergo surgical resection of the primary lesion(s) as judged by the investigator (Resectable and Borderline Resectable Cohorts only).
• Planned for adjuvant (Resectable and Borderline Resectable Cohorts) or first-line (Locally Advanced Cohort) therapy with FOLFIRINOX or a gemcitabine-based regimen, either as part of routine care or in combination with an investigational agent(s) within another clinical trial. Participants may have received pre-operative therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Adequate organ function as defined by the following laboratory results obtained within 28 days prior to enrollment date:

• Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L.
• Hemoglobin ≥ 9 g/dL.
• Platelets ≥ 75 x 10^9/L.
• Prothrombin time test and international normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.5 x Upper Limit of Normal (ULN).
• Total bilirubin ≤ 1.5 x ULN. Isolated bilirubin > 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%.
• Aspartate aminotransferase (AST) and alanine aminotransferase (AST) ≤ 1.5 x ULN. If liver metastases are present, AST and ALT ≤ 5 x ULN is permitted.
• Albumin ≥ 25 g/L.
• One of the following:

• Creatinine ≤ 1.5 x ULN.
• Calculated creatinine clearance (as calculated by Cockcroft-Gault formula) ≥ 40 mL/min.
• 24-hour urine creatinine clearance ≥ 40 mL/min.
• Life expectancy greater than 90 days as judged by the investigator.
• Able to give informed consent for the study procedures defined in this protocol.
• Measurable disease by RECIST 1.1. For those in the Resectable and Borderline Resectable Cohorts, measurable disease must be present prior to resection surgery.

Exclusion criteria

• Presence of distant or lymph node metastases. Individuals with metastatic PDAC are not eligible.
• Currently receiving adjuvant (Resectable and Borderline Resectable Cohorts) or systemic (Locally Advanced Cohort) anti-cancer therapy (chemotherapy or any other anti-cancer agent) with one exception: pre-operative therapy is permitted.
• Not fit for chemotherapy as judged by the investigator.
• Presence of brain metastases.
• Positive pregnancy test.
• Unable to comply with the study assessments and procedures defined in this protocol.
• Individuals who are otherwise judged by the investigator to be unfit to proceed with this protocol.