Unresectable pancreatic neuroendocrine carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed pancreatic neuroendocrine carcinoma 2) No indication for surgical resection 3) 20 years of age or over 4) ECOG performance status 0-2 5) Refractory or intolerant to platinum-based regimen 6) Having evaluable lesion by CT 7) No previous chemotherapy within 3 weeks 8) Adequate organ function 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) NET G1 or G2 by WHO 2010 criteria 2) Interstitial pneumonia or plumonary fibrosis 3) Metastasis to the central nervous system 4) Concomitant malignancy within 3 years 5) Active infection (exept for hepatitis B or C viral infection) 6) Active gastrointestinal ulcer 7) Severe or uncontrollable complications, such as cardiovascular impairment, infection, diabetes mellitus, and pulmonary disease 8) Severe mental disorder 9) Continuous administration of steroid or immunosuppressant 10) Prior treatment of mTOR inhibitor 11) Pregnant or lactating women and women of childbearing age who were not using effective contraception 12) Patients who was judged to be inappropriate for this study by each investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, time to treatment failure, response rate, disease control rate, adverse events | — |
Countries
Japan
Contacts
National Cancer Center Hospital East Department of Hepatobiliary and Pancreatic Oncology