Advanced biliary tract cancer refractory to standard rate gemcitabine
Conditions
Interventions
Gemcitabine(1000mg/m2, div, over 100 minutes, day1), S-1(40mg/m2 twice daily, oral, day1-7), every two weeks. Treatment is repeated until disease progression, patient'
s refusal, or serious adverse event.
Sponsors
Yokohama Clinical Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer 2) Recurrent or unrespectable biliary tract cancer 3) Histologically proven papillary adenocarcinoma, tubular adenocarcinoma, or adenosquamous carcinoma for extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer patients. Histologically proven adenocarcinoma for intrahepatic cholangiocarcinoma 4) Measurable disease as defined by Revised RECIST guideline (version 1.1) 5) Without CNS metastasis 6) Without moderate or more ascites/pleural effusion 7) Refractoy to one prior gemcitabine or gemcitabine based chemotherapy, defined by RECIST version 1.1 8) No previous therapy against biliary tract cancer 9) No previous chemotherapy or radiotherapy against any other malignancies within 3 years 10) ECOG PS of 0, 1, 2 11) Sufficient oral intake 12) Aged 20 years old or over 13) At least 2 weeks have passed after the prior therapy 14) Adequate organ function 15) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Simultaneous or metachronous (within 3 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 or severe mental disorder 4) Patients requiring systemic steroids medication 5) Plumonary fibrosis or interstitial pneumonia 6) Uncontrollable watery diarrhea 7) Active bacterial or fungous infection 8) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, uncontrollable diabetes millitus etc 9) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium 10) Patients who can't receive neither iodic drug nor gadolinium because of drug allergy 11) Prior history of chemotherapy with pyrimidine fluoride for the other disease within the 5 years 12) Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reponse rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Progression-free survival Adverse events Serious adverse events | — |
Countries
Japan
Contacts
Public ContactSatoshi Kobayashi
Kanagawa Cancer Center Division of Hepatobiliary and Pancreas Oncology
Outcome results
None listed