Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX

Prior treatment

• Any other malignancy within 5 years prior to randomization, with the exception of cured in-situ carcinoma or basal cell carcinoma.
• Patients with distant metastases and/or can not complete resection.
• Patients who have chemotherapy and surgery contraindications.
• Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.
• Participated in other trial within 30 days prior to the first dose of study treatment.

Other illness

• Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
• Active HIV, HBV, HCV infection.
• Combined with uncontrollable systemic diseases (such as unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, severe pericardial disease history and other cardiovascular diseases; hypertension \> grade 2 after medication \[CTCAE v5.0\], diabetes, etc.)
• Presence of severe gastrointestinal disease (including active bleeding, \> grade 1 obstruction \[CTCAE v5.0\], or \> grade 1 diarrhea \[CTCAE v5.0\])
• History of allergy or hypersensitivity to drug or any of their excipients.

Lab values

• Documented serum albumin ≤3 g/dL

Age

• Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception.

Other

• Patients who are not suitable to participate in this trial for any reason judged by the investigator

• Age: ≥18 years old.
• Histologically or cytologically proven pancreatic ductal adenocarcinoma.
• Multidisciplinary assessment as high-risk resectable disease.
• At least one measurable lesion (according to RECIST v1.1).
• No prior antitumor therapy for pancreatic cancer.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 \~ 1.
• The expected survival time ≥3 months.
• Subject has adequate biological parameters as demonstrated by the following blood counts:
  • Absolute neutrophil count (ANC) ≥1.5×10\^9/L Platelet count ≥100×10\^9/L Hemoglobin (Hgb) ≥90 g/L White blood cell（WBC）≥3.0×10\^9/L
• Adequate hepatic function as evidenced by:
  • Serum total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) 、alkaline phosphatase（ALP）and alanine aminotransferase (ALT) ≤2.5 × ULN
• Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 × ULN or creatinine clearance ≥60 mL/min.
• Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.