NaliCap (Irinotecan Liposome (Nal-IRI)/Capecitabine) vs. NAPOLI (Nal-IRI/5-FU/LV) ) in Advanced Pancreatic Cancer

Inclusion Criteria:

1. Signed informed consent
2. Age>20 years at time of study entry
3. Histologically confirmed pancreatic ductal adenocarcinoma
4. Advanced stage (unresectable, recurrent)
5. Gemcitabine-pretreated for advanced pancreatic cancer
6. Eastern Cooperative Oncology Group(ECOG) performance status 0, 1
7. Adequate organ function
8. Evidence of post-menopausal status or negative urinary or serum pregnancy test forfemale pre-menopausal subjects.
9. Subject is willing and able to comply with the protocol for the duration of the studyincluding undergoing treatment and scheduled visits and examinations including followup.

Exclusion Criteria:

1. Participation in another clinical study with an investigational product (IP) duringthe last 3 weeks
2. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of aninterventional study
3. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy,endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonalantibodies, other investigational agent) 28 days prior to the first dose of study drug
4. Major surgical procedure (as defined by the Investigator) within 28 days prior to thefirst dose of IP. Note: Local surgery of isolated lesions for palliative intent isacceptable.
5. Known brain metastasis or spinal cord compression.
6. History of allogenic organ transplantation
7. Cardiac event during past 6 months
8. Uncontrolled intercurrent illness, including but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, uncontrolled hypertension, unstableangina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronicgastrointestinal conditions associated with diarrhea, or psychiatric illness/socialsituations that would limit compliance with study requirement, substantially increaserisk of incurring AEs or compromise the ability of the patient to give writteninformed consent
9. Active infection including tuberculosis (TB) (clinical evaluation that includesclinical history, physical examination and radiographic findings, and TB testing inline with local practice), hepatitis B (known positive hepatitis B virus (HBV) surfaceantigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Subjects with a past or resolved HBV infection (defined as thepresence of hepatitis B core antibody [anti-HBc (hepatitis B core antigen)] andabsence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody areeligible only if polymerase chain reaction is negative for HCV RNA.
10. Female subjects who are pregnant or breastfeeding or male or female subjects ofreproductive potential who are not willing to employ effective birth control fromscreening to 90 days after the last dose of IP.
11. Known allergy or hypersensitivity to any of the study drugs or any of the study drugexcipients.
12. Judgment by the investigator that the patient is unsuitable to participate in thestudy and the patient is unlikely to comply with study procedures, restrictions andrequirements.