SorAfenib Versus RADIOEMBOLIZATION in Advanced Hepatocellular Carcinoma

PHASE3CompletedINTERVENTIONAL
Enrollment

496

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Liver Carcinoma
Interventions
DRUG

sorafenib

Patients will receive continuous oral treatment with 800 mg of sorafenib daily (Nexavar, Bayer HealthCare Pharmaceuticals-Onyx Pharmaceuticals). Treatment interruptions and dose reductions (to 400 mg once daily) will be permitted for drug-related adverse effects. At the discretion of the investigator, the dose may be re-escalated to after the resolution of the adverse event.

DRUG

SIR-Sphere

The first step will check patient eligibility and prepare conditioning by performing selective mesenteric and hepatic angiography (to document the arterial tumor supply and to occlude extrahepatic vessels) and 99mTc-macroaggregated albumin scintigraphy. The second step is RADIOEMBOLIZATION therapy. One to two weeks after patient eligibility and conditioning, treatment is performed with SIR-Sphere (SIRTEX Medical Ltd.,Lane Cove,Australia).

Trial Locations (26)

13009

Institut Paoli Calmettes #7, Marseille

13385

CHU Marseille Hôpital La Timone #23, Marseille

14033

Hôpital Côte de Nacre #4, Caen

21000

CHU Dijon Hôpital Bocage #22, Dijon

25030

CHRU Besançon Hôpital Jean Minjoz #21, Besançon

33604

Hôpital Haut Leveque #14, Pessac

34295

Hôpital Saint Eloi #8, Montpellier

38043

CHU Grenoble #5, Grenoble

42270

CHU Saint Etienne Hôpital Nord #17, Saint-Priest-en-Jarez

44093

Hotel Dieu #10, Nantes

49933

CHU Angers #3, Angers

51100

CHU Robert Debré #28, Reims

54511

Hôpital de Brabois #9, Nancy

67098

Hôpital de Hautepierre #18, Strasbourg

69003

Hôpital Edouard Herriot #6, Lyon

69004

Lyon La croix Rousse #27, Lyon

75908

Hôpital Européen Georges Pompidou #13, Paris

80054

CHU Amiens #2, Amiens

86021

CHU Poitiers La Milétrie, Poitiers

92110

Hopital beaujon #1, Clichy

92140

Hôpital Antoine Béclère #29, Clamart

93140

Hôpital Jean Verdier #25, Bondy

94000

Henri Mondor #24, Créteil

94275

Paul Brousse #19, Villejuif

94805

Institut Gustave Roussy #20, Villejuif

06002

Hôpital de L'Archet #11, Nice

All Listed Sponsors
collaborator

Ministry of Health, France

OTHER_GOV

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT01482442 - SorAfenib Versus RADIOEMBOLIZATION in Advanced Hepatocellular Carcinoma | Biotech Hunter | Biotech Hunter