Randomized Phase II Study of NaliCap (Irinotecan Liposome/Capecitabine) Compared to NAPOLI (Irinotecan Liposome/5-fluorouracil/Leucovorin) in Gemcitabine-pretreated Advanced Pancreatic Cancer
This is an open label, randomized phase 2 study of NaliCap (irinotecan liposome/Capecitabine) compared to NAPOLI (irinotecan liposome/5-FU/LV) in gemcitabine-pretreated advanced pancreatic cancer patients.
• Signed informed consent
• Age\>20 years at time of study entry
• Histologically confirmed pancreatic ductal adenocarcinoma
• Advanced stage (unresectable, recurrent)
• Gemcitabine-pretreated for advanced pancreatic cancer
• Eastern Cooperative Oncology Group(ECOG) performance status 0, 1
• Adequate organ function
• Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects.
• Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.