A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment

Inclusion Criteria:

• Histological or cytologically confirmed adenocarcinoma of the pancreas that has notbeen previously treated in the metastatic setting.

• Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior toscreening.

• Subject has one or more metastatic lesions measurable by computed tomography (CT)scan (or magnetic resonance imaging (MRI), if the subject is allergic to CT contrastmedia) according to RECIST Version 1.1 criteria.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Subject has adequate biological parameters as demonstrated by the following bloodcounts:(a) Absolute neutrophil count (ANC) ≥2000/mm3 without the use of hemopoieticgrowth factors within the last 7 days prior to randomisation (b) Platelet count ≥100,000/mm3 (c) Haemoglobin (Hgb) ≥9 g/dL obtained ≤14 days prior to randomisation.

• Adequate hepatic function as evidenced by: (a) Serum total bilirubin ≤1.5x ULN (biliary drainage is allowed for biliary obstruction), and (b) Aspartateaminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x upper limit ofnormal (ULN) (≤5x ULN is acceptable if liver metastases are present).

• Adequate renal function as evidenced by creatinine clearance ≥30 mL/min.

• Adequate coagulation studies (obtained ≤14 days prior to randomisation) asdemonstrated by prothrombin time and partial thromboplastin time within normallimits (≤1.5xULN ).

Exclusion Criteria:

• Prior treatment of pancreatic cancer in the metastatic setting with surgery,radiotherapy, chemotherapy or investigational therapy

• Prior treatment of pancreatic adenocarcinoma with chemotherapy in the adjuvantsetting, except those where at least 12 months have elapsed since completion of thelast dose and no persistent treatment-related toxicities are present.

• Subject has only localised advanced disease.

• Documented serum albumin <3 g/dL

• Known history of central nervous system (CNS) metastases.

• Clinically significant gastrointestinal disorder

• History of any second malignancy in the last 2 years

• Concurrent illnesses that would be a relative contraindication to trialparticipation

• Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1

• Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma

• Known low or absent dihydropyrimidine dehydrogenase (DPD) activity