biliary tract cancer biliary tract cancer
Conditions
Interventions
(1) GCD therapy The following agents are administered every 3 weeks until tumor progression or unacceptable adverse events
Gemcitabine, 1,000 mg/m2, days 1 and 8
Cisplatin, 25 mg/m2, days 1 and 8
Durv
GCD, GCS
Sponsors
Yamashita Taro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histologically or cytologically diagnosed as adenocarcinoma or adenosquamous carcinoma 2) radiollogically diagnosed as unresectable or recurrent biliary tract cancer 3) previously treated by GCS or GCD therapy 4) 20 years or older 5) ECOG Performance status 0 or 1 6) patients capable of oral intake (in GCS group) 7) preservation of major organ function 8) written informed consent by patient
Exclusion criteria
Exclusion criteria: 1) double cancer 2) active infection 3) pregnant or lactating women, or women of childbearing potential 4) mental disorder 5) auto-immune disease 6) severe complication 7) metastases to central nervous system 8) contraindication for the study drug 9) patients who investigator regards as inappropriate for candidate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression-free survival from first-line therapy, Overall survival from first-line therapy, Objective response rate, Tumor control rate, Adverse events, Subsequent therapy | — |
Contacts
Public ContactTakeshi Terashima
Kanazawa University Hospital
Outcome results
None listed