Pilot Study of Personalized First-line Chemotherapy Choice for Patients With Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures (PACsign)
The aim of this study is to assess the clinical value of 5 transcriptomic signatures prognostic of chemotherapeutic sensitivity to improve the Objective Response Rate (ORR) of first-line (L1). Chemotherapy regimen (FOLFIRINOX vs Gem-nabP) will be selected based on transcriptomic signatures applied to the pre-therapeutic liver biopsy of newly diagnosed PDAC patients.
• Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
• Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
• Histologically or cytologically proven Pancreatic Ductal Adenocarcinoma (PDAC).
• Metastatic disease.
• Measurable or evaluable lesions according to RECIST v1.1 criteria.
• First-line therapy (previous neoadjuvant/adjuvant chemotherapy not allowed).
• Age ≥ 18 years (no upper limit, patients ≥ 75 years old must have a G8 score ≥ 14).
• 3\. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
• Availability of tumor tissue sample from the primary pancreatic tumor or liver metastasis (chemo-naïve) before inclusion in step 1.
⁃ Adequate organ function, as defined by the following (blood test ≤ 7 days prior to inclusion):
∙ Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN) (≤ 5 ULN in case of liver metastases)
‣ Total serum bilirubin ≤ 1.5 ULN
‣ Serum albumin ≥ 28 g/L
‣ Hemoglobin ≥ 9.0 g/dl
‣ Absolute neutrophil count (ANC) ≥ 1,500/μL
‣ Platelets ≥ 100,000/μL
‣ Creatinine clearance ≥ 50 mL/min (MDRD).
⁃ No Dihydropyrimidine dehydrogenase (DPD) deficiency (normal uracil level).
⁃ Life expectancy ≥ 3 months.
⁃ a. Evidence of post-menopausal status b. (or) negative urinary or serum pregnancy test for female pre-menopausal patients.
⁃ Registration in a National Health Care System.