Efficacy and Safety of Concurrent TACE and Sorafenib in Patients With HCC and Extrahepatic Metastasis (COTSOM Study)

PHASE2UnknownINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

December 31, 2017

Study Completion Date

June 30, 2018

Conditions
Hepatocellular CarcinomaMetastasis
Interventions
PROCEDURE

Conventional Transarterial Chemoembolization (TACE)

On demand conventional TACE will be performed in all the patients after enrollment and can be continued until intrahepatic CR, TACE failure or consent withdrawal. Sorafenib will be started 3-7 days after the first and each subsequent TACE and stopped one day before next TACE and will be continued until sorafenib failure, consent withdrawal or condition worsening by clinical decision.

DRUG

sorafenib

Sorafenib will be started 3-7 days after the first and each subsequent TACE and stopped one day before next TACE and will be continued until sorafenib failure, consent withdrawal or condition worsening by clinical decision.

Trial Locations (1)

Unknown

Asan Medical Center, Seoul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Asan Medical Center

OTHER