The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5FU/LV) treatment as adjuvant therapy in patients with resected pancreatic cancer.
Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
ECOG performance status 0 or 1.
Life expectancy of greater than or equal to 6 months.
Full recovery from surgery and patient is scheduled to start treatment within 3 weeks to 12 weeks after surgery.
Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma.
CA19-9 exceeding normal value within 14 days prior to enrollment.
Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
Parallel
HR070803
DrugHR070803 60 mg/\^2 D1 over 90 minutes.
Oxaliplatin
DrugOxaliplatin 85 mg/\^2 D1 over 2 hours.
Tegafur
Druginitial dose of S-1 is determined according to the body surface area，orally, D1-7.
Folinic acid
DrugFolinic acid 400 mg/\^2 D1
5-Fluorouracil
Drug5-FU 2400 mg/\^2 D1 IV continuous infusion over 46 hours
1-year Disease-free survival rate
Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause.
Overall survival (OS)
OS is defined as the time from date of randomization until the date of death from any cause.
Disease-free survival（DFS）
Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause.
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