non-resectable biliary tract cancer or recurrent biliary tract cancer post surgical treatment
Conditions
Interventions
Gemcitibine 1000 mg/m2 is infused in 30 min on day 1 and 8, and S-1 60 mg/m2 is given orally daily for 14 consecutive days. The cycle is repeated every 3 weeks until disease progression, unacceptable
Sponsors
Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with cytologically or histologically proved non-resectable biliary tract cancer (intrahepatic bile duct cancer, extrahepatic bile duct cancer, gall bladder cancer and ampulla vater cancer) or recurrent biliary tract cancer post surgical treatment 2. Patients of age >=20 years 3. Patients with PS of 0-2 4. Patients without the prior treatment except surgery 5. Patients with an adequate organ function 6. Patinets without other serious comorbid disease 7. Patients with an ability of oral intake 8. Patients with an estimated life expectancy of more than 3 months 9. Patients providing written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with interstitial pneumonia or pulmonary fibrosis 2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months 3. Patients with severe active infection 4. Patients who are pregnant or lactating, or have an intention to get pregnant 5. Patients with a history of severe drug allery 6. Patients with other serious comorbid disease 7. Patinets with serious mental disease 8. Patients who are judged inappropriate for the entry into the study by the investigater
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate (RR) adverse events | — |
Countries
Japan
Outcome results
None listed