Overview

A Randomized Study of GEMOX With or Without Cetuximab in Locally Advanced and Metastatic BTC

Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
Summary
The primary objective is to investigate the objective response rate in patients receiving GEMOX (gemcitabine plus oxaliplatin) plus cetuximab as first line treatment in advanced or metastatic unresectable BTC biliary tract cancer compared to patients receiving the same chemotherapy without cetuximab. The secondary objectives include the exploration of the effect of the multimodality strategy on progression-free and overall survival, biomarker prediction, and toxicity.
Phase:
Phase 2
Details
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborators:
Chang Gung Memorial Hospital
China Medical University Hospital
Kaohsiung Medical University
Kaohsiung Veterans General Hospital.
Mackay Memorial Hospital
National Cheng-Kung University Hospital
National Taiwan University Hospital
Taichung Veterans General Hospital
Taipei Veterans General Hospital, Taiwan
Tri-Service General Hospital
Treatments:
Cetuximab
Gemcitabine
Oxaliplatin