OPTIMIS - Outcomes of HCC patients treated with TACE followed or not followed by sorafenib and the influence of timing to initiate sorafenib

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26404
• EU PAS number:
  EUPAS4564
• Study ID:
  26404
• Official title and acronym:
  OPTIMIS - Outcomes of HCC patients treated with TACE followed or not followed by sorafenib and the influence of timing to initiate sorafenib
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Brazil

  Canada

  China

  Egypt

  France

  Greece

  Hungary

  India

  Indonesia

  Japan

  Kazakhstan

  Korea, Republic of

  Mexico

  Netherlands

  Pakistan

  Russian Federation

  Singapore

  Slovakia

  Sweden

  Switzerland

  Taiwan

  Thailand

  Türkiye

  Viet Nam
• Study description:
  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.
• Study status:
  Finalised

Research institution and networks

Institutions

Bayer AG

Multiple centres: 25 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 05/12/2012

Actual: 05/12/2012

Study start date

Planned: 01/09/2013

Actual: 28/10/2013

Date of final study report

Planned: 30/06/2018

Actual: 07/06/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

OPTIMIS_PRO

Updated protocol

OPTIMIS_PRO_v3_2015-09-04 FINAL

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable