cholangiocarcinoma
Conditions
Interventions
two cycles of chemotherapy with gemcitabine (800 mg/m2 on days 7 and 21) plus S-1 (80 mg/body daily on days 1 to 21 every 4 weeks), followed by surgery
Sponsors
Mie University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) cholangiocarcinoma as following: (1) main, bilateral, or contralateral portal vein and/or hepatic artery invasion with or without possible vascular reconstruction; or (2) invasion of the right side of the umbilical portion (U portion) and the left side of the origin of the right posterior portal vein (P portion); or (3) regional lymph node metastasis. 2) Performance Status (ECOG):0 or 1 3) Patient's agreement to this study
Exclusion criteria
Exclusion criteria: 1) patients with allergic reaction for TS-1 and gemecitabine 2) patients with severe hepatic disorder (AST or AL: 3 times of normal range or more) 3) patients with severe repeated cholangitis 4) Patients found to be wanting by principal investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival: OS | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival, safety evaluation, pathological effects of neoadjuvant treatment | — |
Countries
Japan
Contacts
Public ContactNaohisa Kuriyama
Mie University school of medicine Hepatobiliary Pancreatic and Transplant Surgery
Outcome results
None listed