Trastuzumab is approved for the treatment of HER2-positive breast cancer and gastric cancer. The recent study showed that HER2 overexpression or amplification is noted about 5-15% of total biliary tract cancer patients and have shown efficacy in small basket trials. The aim of this study is to evaluate the efficacy and safety of trastuzumab in the combination of mFOLFOX for gemcitabine+cisplatin refractory biliary tract cancer patients.
This phase II study is designed to see whether trastuzumab-pkrb+FOLFOX is active as 2nd or 3rd line treatment for HER2-positive biliary tract cancer patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Herzuma (Trastuzumab-pkrb) 4mg/kg after 6mg/kg loading D1 5FU 400mg/m2 bolus+2400mg/m2 infusion for 46 hrs D1 Leucovorin 200mg/m2 D1 Oxaliplatin 85mg/m2 D1 every 2 weeks
Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine
Seoul, South Korea
Objective response rate (ORR)
rate of patients with complete remission (CR) or partial remission (PR) based on RESIST1.1.
Time frame: up to 2 years
Progression-free survival (PFS)
PFS is defined as time interval from cycle 1 day 1 to tumor progression/death/last follow-up
Time frame: up to 2 years
Disease control rate (DCR)
DCR is rate of patients with CR, PR, or SD per RECIST 1.1.
Time frame: up to 2 years
Overall survival (OS)
OS is defined as time interval from cycle 1 day 1 to tumor death/last follow-up.
Time frame: up to 2 years
Incidence of treatment related adverse events (TRAE)
Incidence of treatment related adverse events (TRAE) will be assessed using NCI CTCAE v5.0 and tabulated and reported.
Time frame: up to 2 years
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