In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin,efficacy of mFOLFOX/FOLFIRI vs mFOLFOX will be evaluated at randomized phase 2 trial.
Age ≥ 19 years.
Diagnosed with biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, or ampulla of Vater cancer.
Either unresectable advanced disease or recurrence after curative surgery.
ECOG (Eastern Cooperative Oncology Group) performance status of 0-2
Patients with prior exposure to oxaliplatin or irinotecan in previous cancer treatments.
Patients with metastatic or unresectable biliary tract cancer who have received second- line or higher chemotherapy.
Pregnant or breastfeeding women.
Patients with a history of other malignancies within the past 3 years, except for papillary or follicular thyroid cancer.
Parallel
Oxaliplatin, 5FU, leucovorin
DrugAdministered as a single regimen every 2weeks
Oxaliplatin, 5FU, leucovorin/Irinotecan , 5FU, leucovorin,
DrugAdministered alternately every 2weeks
6months overall survival rate
at 6months from intervention treatment, overall survival rate
response rate
complete response,partial response
disease control rate
complete response, partial response, stable disease
progression free survival
from treatment start to progression or any cause of death
Number of participants with Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0
percentage of all patients
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