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Trastuzumab

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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

HERZUMA+mFOLFOX

Choong-kun Lee

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.

Trastuzumab-pkrb Combined With Modified FOLFOX-6 in Biliary Tract Cancer Patients Progressed on First Line Therapy

A Phase II Trial of Trastuzumab-pkrb Combined With Modified FOLFOX-6 in Biliary Tract Cancer Patients Progressed on First Line Therapy

rate of patients with complete remission (CR) or partial remission (PR) based on RESIST1.1.

PFS is defined as time interval from cycle 1 day 1 to tumor progression/death/last follow-up

DCR is rate of patients with CR, PR, or SD per RECIST 1.1.

OS is defined as time interval from cycle 1 day 1 to tumor death/last follow-up.

Incidence of treatment related adverse events (TRAE) will be assessed using NCI CTCAE v5.0 and tabulated and reported.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trastuzumab-pkrb Combined With Modified FOLFOX-6 in Biliary Tract Cancer Patients Progressed on First Line Therapy	NCT04722133	HER2 Positive A...	HERZUMA+mFOLFOX	19 Years -	Yonsei University
Trastuzumab-pkrb Combined With Modified FOLFOX-6 in Biliary Tract Cancer Patients Progressed on First Line Therapy	NCT04722133	HER2 Positive A...	HERZUMA+mFOLFOX	19 Years -	Yonsei University

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