Overview

Trastuzumab Biosimilar (Samfenet®) Plus Treatment of Physician's Choice (TPC) in Patients With HER2-positive Solid Tumor

Status:
Not yet recruiting

Trial end date:
2019-12-30

Target enrollment:

Participant gender:

Summary

HER2 signaling pathway abnormalities or HER2 overexpression can be seen in various types of solid tumors apart from breast cancer or hepatic cancer. In this regardHER2 targeting therapy has been proven to be effective in colorectal cancer, gallbladder cancer, and salivary gland tumors. Although HER2 targeted-treatment Trastuzumab biosimilar is clinically being used after gaining official permission recently, clinical data for this use is still lacking, especially regarding experiences of combination with various cytotoxic chemotherapy agents. Notably, techniques to separate and extract a small sized ciculating tumor DNA (ctDNA) in patient's blood originated from a tumor is being developed and improved along with introduction of Next-generation sequencing (NGS) technique enabling a comprehensive genetic testing. The aim of this study is to evaluate the efficacy and safety of Trastuzumab biosimiler and to investigate the association between ctDNA and clinical outcomes such as disease response, progression-free survival, and overall survival.

Phase:

Phase 2

Details

Lead Sponsor:

Jin-Hee Ahn

Collaborator:

Asan Medical Center

Treatments:

Gemcitabine
Irinotecan
Trastuzumab