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

HER2 Positive Advanced/Metastatic/Nonresectable Biliary Tract Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Biliary Tract Neoplasms
HER2 Positive Advanced/Metastatic/Nonresectable Biliary Tract Cancer

Clinical Trial Details

NCT number	NCT04722133
Study type	Interventional
Source	Yonsei University
Contact
Status	Completed
Phase	Phase 2
Start date	June 23, 2020
Completion date	June 14, 2023

View Details

See also
	Status	Clinical Trial	Phase
	Not yet recruiting	`NCT05749900` - First-line Trastuzumab, Gemcitabine, Cisplatin and Nivolumab in Advanced HER2- Positive Biliary Tract Cancer: a Multicenter, Open-label, Single-arm Phase Ib/II Trial (HERBOT)	Phase 1/Phase 2