Pancreatic Adenocarcinoma Signature Stratification for Treatment – 01 (PASS-01)

Aim/goals:

1. To evaluate mFFX and GA in patients with untreated metastatic pancreatic ductal adenocarcinoma.
2. To explore biomarker correlation to treatment response and patient outcomes.
3. To evaluate concordance between patient response and outcomes with patient derived organoid (PDO) profiles, signatures and pharmacotyping.
4. Compile a detailed genomic annotation of advanced PDAC patients on first line chemotherapy.

This is a randomized multicentre clinical trial with a large translational component. The trial will evaluate the two standard chemotherapy regimens: mFFX and GA, in patients with untreated metastatic pancreatic ductal adenocarcinoma (PDAC). Globally, approximately 150 patients will be randomized to receive one of the two standard of care regimens. Only Canadian patients would be included in the MOHCC cohort (n80). Patients will undergo a biopsy of their tumour for molecular profiling (WGS and RNAseq), PDO establishment and pharmacotyping to look for specific markers that show why one chemotherapy may work better than another. Specific changes in the DNA can also be found which may match patients to specific second-line drugs (subsequent to the study). Integrated into this trial are other correlative components including serial cell free ctDNA, circulating tumour cells (CTC), and intra-tumoral immuno-oncologic analyses. We will also test for other markers that have been shown in our previous work (COMPASS Trial NCT02750657) to be promising predictors of how a tumour will behave or respond to drugs.