A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)

Inclusion Criteria: * Histologically proven metastatic adenocarcinoma of the pancreas * Progression documented after gemcitabine-Abraxane, or gemcitabine monotherapy * Signed written informed consent * Age ≥ 18 * ECOG PS 0/1 at study entry * Measurable disease * Adequate renal (serum creatinine ≤ 1.5x upper reference range), liver (total bilirubin ≤ 1.5x upper reference range) and hematopoietic functions (PMN ≥ 1,5x109/L, platelets ≥ 100x109/L, hemoglobin ≥ 9g/dl) * INR/PTT ≤ 1.5x ULN * Life expectancy of at least 12 weeks * Effective contraception for both male and female patients if the risk of conception exists during treatment and for one month after the last administration * Peripheral Neuropathy \< grade 2 Exclusion Criteria: * Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension * History of myocardial infarction, deep venous or arterial thrombosis, CVA during the last 6 months * Known hypersensitivity to any of the components, including excipients, of study treatments * Previous malignancy in the last past 3 years except basal cell cancer of the skin or preinvasive cancer of the cervix or carcinoma in situ of any type * Pregnancy or breast feeding * Medical or psychological conditions that would not permit the patient to complete the study or sign inform consent * Unstable angina, congestive heart failure ≥NYHA class II * Uncontrolled hypertension despite optimal management (systolic blood pressure \>150 mmHg or diastolic pressure \> 90mmHg) * HIV infection * Complete DPD deficiency * Liver failure, cirrhosis Child Pugh B or C * Active chronic hepatitis B or C with a need for antiviral treatment * Brain metastasis * Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of treatment * History of organ allograft * Ongoing uncontrolled, serious infection * Renal failure requiring dialysis * Patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study