Sequential Use of AG and mFOLFIRINOX as Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer

Inclusion Criteria:

• Pathologically (histologically or cytologically) confirmed pancreatic ductaladenocarcinoma (PDAC).

• No evidence of distant metastasis (such as liver, peritoneum, lung) evaluated byabdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imagingexaminations would be used if necessary.

• Initial assessment for definitive resectable tumors (resectability judgment is basedon CT enhanced scan or magnetic resonance imaging, NCCN2018 first edition standard).

• ECOG score 0 or 1.

• Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 xULN.

• ALT and AST are less than 2 x ULN.

• If biliary obstruction is observed, biliary decompression should be performed whenthe patient is randomly assigned to receive neoadjuvant chemotherapy.

• Leukocyte count (> 3.5 x 10^6 /mL), neutrophil count (> 1.5 x 10^6 /mL), plateletcount (> 80 x 10^6 /mL), hemoglobin (> 9 g/dL).

• Signed informed consent.

Exclusion Criteria:

• History of malignance treatment in the past, excluding basal and cutaneous squamouscell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma

• Tumor is a local recurrent lesion.

• Imaging confirmed severe portal hypertension / cavernous transformation.

• Ascites

• Gastric outlet obstruction

• Respiratory failure requires supplementation of oxygen.

• Immune deficiency syndrome, such as active tuberculosis and HIV infection.

• Hematological precancerous diseases, such as myelodysplastic syndromes.

• Major cardiovascular diseases (including myocardial infarction, unstable angina,congestive heart failure, severe uncontrolled arrhythmia) during the past six monthsof enrollment.

• Evidence of clinical-related or previous interstitial lung disease, such asnoninfectious pneumonia or pulmonary fibrosis, or baseline chest CT scan or chestX-ray findings

• Previous or physical findings of central nervous system disease, except foradequately treated (e.g. primary brain tumors, uncontrolled seizures or strokes withstandard medications)

• Preexisting neuropathy > 1 (NCI CTCAE).

• Allograft requires immunosuppressive therapy or other major immunosuppressivetherapies.

• Severe serious wounds, ulcers or fractures.

• Confirmed coagulant disease.

• Clinical evaluation is unacceptable.