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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
408
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.
Time frame: Approximately 3 years.
Overall survival (OS)
Time frame: Approximately 5 years.
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Gemcitabine: i.v. infusion
Capecitabine: Oral