The purpose of this study is to determine whether sunitinib as second-line treatment in advanced biliary tract carcinoma
Phase II study of sunitinib as second-line treatment in advanced biliary tract carcinoma: multicenter, multinational study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Sunitinib 37.5 mg orally once daily continuously, comprising a 4-week cycle
Samsung Medical Center
Seoul, South Korea
Time to progression
Time frame: 12months
Safety profile
Time frame: 12 months
Response rate
Time frame: 12 months
Duration of response
Time frame: 12 months
Overall survival
Time frame: 12 months
Correlative analyses: EGFR mutational analysis, EGFR immunohistochemical staining, RAS mutational analysis, KIT, PDGFRA, PDGFRB, Beta-Catenin (CTNNB1) mutations
Time frame: 12 months
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