This study will evaluate the efficacy and safety of adjuvant therapy with liposomal irinotecan in combination with oxaliplatin, and S-1 compared with capecitabine combined with capecitabine in participants with pancreatic ductal adenocarcinoma after radical surgery.
Patients able and willing to provide a written informed consent aged 18-75 years.
Histologically confirmed resected ductal pancreatic adenocarcinoma (including adenosquamous carcinoma).
Undergone radical resection and confirmed macroscopic complete resection (R0 and R1).
Full recovery after surgery; able to start adjuvant treatment within 12 weeks after surgery.
Patients with other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, pancreatoblastoma, and solid-pseudopapillary tumor.
Macroscopic incomplete tumor removal (R2 resection).
Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
Presence or history of metastatic or locally recurrent pancreatic adenocarcinoma.
Parallel
Liposomal Irinotecan
DrugLiposomal Irinotecan：i.v. infusion
Oxaliplatin
DrugOxaliplatin;：i.v. infusion
S-1
DrugS-1: Oral
Gemcitabine
DrugGemcitabine: i.v. infusion
Capecitabine
DrugCapecitabine: Oral
Disease-free survival (DFS)
Disease-free survival is defined as the time from the date of randomization to the date of disease recurrence or death from any cause (whichever occurs first). Disease recurrence is defined as evidence of disease recurrence demonstrated by imaging assessment with CT or MRI scan and/or pathological diagnosis indicated by biopsy.
Overall survival (OS)
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