advanced biliary tract cancer
Conditions
Interventions
GEM: 1000 mg/m2 (day 1,8) CDDP: 25 mg/m2 (day 1,8) S-1: dose escalation (day1-14) Every 3 weeks
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as advanced biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder carcinoma and ampullary carcinoma 2) No previous therapy against biliary tract cancer 3) ECOG PS of 0 or 1 4) Aged 20 to 80 years old 5) Sufficient oral intake 6) Adequate organ functions 7) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy 2) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant 3) Psychosis 4) Patients requiring systemic steroids medication 5) Interstitial pneumonia 6) Active bacterial or fungous infection 7) Severe complication 8) Patients who cannot receive neither iodic drug nor gadolinium because of drug allergy 9) Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate, progression-free survival, overall survival | — |
Countries
Japan
Contacts
Public ContactHirokazu Shoji
National Cancer Center Hospital Hepatobiliary and Pancreatic Oncology Division
Outcome results
None listed