Clinical Trials Directory

Trials / Completed

CompletedNCT01933945

Outcomes of HCC (Hepatocellular Carcinoma) Patients Treated With TACE (Transarterial Chemoembolization) and Early, Not Early or Not at All Followed by Sorafenib

OPTIMIS - Outcomes of HCC Patients Treated With TACE Followed or Not Followed by Sorafenib and the Influence of Timing to Initiate Sorafenib

Status
Completed
Phase
Study type
Observational
Enrollment
1,676 (actual)
Sponsor
Bayer · Industry
Sex
All
Age
Healthy volunteers
Not accepted

Summary

This study will collect data of patients who are treated with TACE followed by sorafenib for hepatocellular carcinoma (HCC) or patients without Sorafenib after TACE. In contrast to a prior observational study on sorafenib (GIDEON study), where pre-treatment with TACE was documented retrospectively, this study will collect more detailed information about the TACE treatment and the status of a patient when treatment with sorafenib is started.

Conditions

Interventions

TypeNameDescription
PROCEDURETACE (transarterial chemoembolization)First treatment for all patients included in the study
DRUGSorafenib (Nexavar, BAY43-9006)

Timeline

Start date
2013-10-28
Primary completion
2017-07-22
Completion
2017-11-10
First posted
2013-09-02
Last updated
2018-11-06

Locations

31 sites across 31 countries: Austria, Brazil, Canada, China, Czechia, Denmark, Egypt, France, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Japan, Kazakhstan, Mexico, Netherlands, Pakistan, Poland, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Vietnam

Source: ClinicalTrials.gov record NCT01933945. Inclusion in this directory is not an endorsement.