Trial Condition(s):

Carcinoma, Hepatocellular

Outcomes of HCC (Hepatocellular carcinoma) patients treated with TACE (transarterial chemoembolization) and early, not early or not at all followed by sorafenib (OPTIMIS)

Bayer Identifier:

16560

ClinicalTrials.gov Identifier:

NCT01933945

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- Patients with histologically/cytologically documented or radiographically diagnosed HCC. Radiographic diagnosis needs typical findings of HCC by radiographic method i.e. on multi-dimensional dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP) or MRI.
 - Patients with BCLC (Barcelona clinic liver cancer staging) stage B or higher.
 - Patients in whom a decision to treat with TACE has been made at time of study enrollment. Patients that have received one TACE in the past also can be enrolled, if the TACE was done at the same site and all required data about such previous TACEs are available. TACE includes both conventional TACE with lipidiol (or similar agents) and chemotherapeutic agent(s) and TACE with DC Beads excluding TAE without chemotherapeutic agent.
 - Patients with unresectable HCC (incurable with curative treatments including resection or ablation or not eligible for resection or local ablation)
 - Patients must have signed an informed consent form
 - Patients must have a life expectancy of at least 8 weeks
Exclusion Criteria
- Patients who have received TACE in the past but the data about TACE required in this protocol are not available
 - Patients who received any systemic anti-cancer therapy prior to the first TACE
 - Patients who are treated according to a trial protocol for intervention including a locoregional therapy or systemic therapy
 - Hospice patients
 - All contra-indications according to the local marketing authorization should be considered.

Trial Summary

Enrollment Goal
1676
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many locations, Austria

Status
Completed
 
Locations

Investigative Site

Many locations, South Korea

Status
Completed
 
Locations

Investigative Site

Many locations, Singapore

Status
Completed
 
Locations

Investigative Site

Many locations, Pakistan

Status
Completed
 
Locations

Investigative Site

Many locations, France

Status
Completed
 
Locations

Investigative Site

Many locations, Poland

Status
Completed
 
Locations

Investigative Site

Many locations, Japan

Status
Completed
 
Locations

Investigative Site

Many locations, Canada

Status
Completed
 
Locations

Investigative Site

Many locations, Sweden

Status
Completed
 
Locations

Investigative Site

Many locations, Denmark

Status
Completed
 
Locations

Investigative Site

Many locations, Czech Republic

Status
Completed
 
Locations

Investigative Site

Many locations, Hungary

Status
Completed
 
Locations

Investigative Site

Many locations, Greece

Status
Completed
 
Locations

Investigative Site

Many locations, Brazil

Status
Completed
 
Locations

Investigative Site

Many locations, Russia

Status
Completed
 
Locations

Investigative Site

Many locations, Slovakia

Status
Completed
 
Locations

Investigative Site

Many locations, China

Status
Completed
 
Locations

Investigative Site

Many locations, India

Status
Completed
 
Locations

Investigative Site

Many locations, Hong Kong, China

Status
Terminated
 
Locations

Investigative Site

Many locations, Thailand

Status
Completed
 
Locations

Investigative Site

Many locations, Egypt

Status
Completed
 
Locations

Investigative Site

Many locations, Kazakhstan

Status
Completed
 
Locations

Investigative Site

Many locations, Spain

Status
Terminated
 
Locations

Investigative Site

Many locations, Netherlands

Status
Completed
 
Locations

Investigative Site

Many locations, Mexico

Status
Completed
 
Locations

Investigative Site

Many locations, Turkey

Status
Terminated
 
Locations

Investigative Site

Many locations, Indonesia

Status
Completed
 
Locations

Investigative Site

Many locations, Switzerland

Status
Completed
 
Locations

Investigative Site

Many locations, Taiwan, China

Status
Completed
 
Locations

Investigative Site

Many locations, Vietnam

Status
Completed
 
Locations

Investigative Site

Many locations, Israel

Status
Terminated
 

Trial Design