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

Phase 2 Completed 36 enrolled Yonsei University

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2020-06-23
Primary completion: 2023-06-14
Completion: 2023-06-14

Publications

Lee CK, Chon HJ, Cheon J, Lee MA, Im HS, Jang JS, Kim MH, Park S, Kang B, Hong M, Kim JW, Park HS, Kang MJ, Park YN, Choi HJ. Trastuzumab plus FOLFOX for HER2-positive biliary tract cancer refractory to gemcitabine and cisplatin: a multi-institutional phase 2 trial of the Korean Cancer Study Group (KCSG-HB19-14). Lancet Gastroenterol Hepatol. 2023 Jan;8(1):56-65. doi: 10.1016/S2468-1253(22)00335-1. Epub 2022 Oct 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trastuzumab	Monoclonal antibody	4 mg/kg	Intravenous
Background	Leucovorin	Small molecule	200 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	fluorouracil	Small molecule	400 mg/m2	—
Background	fluorouracil	Small molecule	2400 mg/m2	—

Indications

No indication recorded.