NCT01556815

Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma

Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Transarterial chemoembolization (TACE) is widely used for unresectable hepatocellular carcinoma (HCC). However, the hypoxia caused by TACE in surviving tumor cell leads to release of angiogenic and growth factors contributing to poor outcome. Sorafenib can block tumor cell proliferation and angiogenesis. The hypothesis is that patients with unresectable HCC may benefit from sorafenib in combination with TACE.

Conditions

• PHENYTOIN/SORAFENIB [VA Drug Interaction]
• Liver Neoplasms
• Carcinoma, Hepatocellular
• Digestive System Neoplasms
• Neoplasms by Site
• Liver Diseases
• Adenocarcinoma
• Carcinoma
• Neoplasms, Glandular and Epithelial
• Neoplasms by Histologic Type
• DOXORUBICIN/TRASTUZUMAB [VA Drug Interaction]
• HBV

Interventions

Type	Name	Description
PROCEDURE	Transarterial Chemoembolization (TACE)	Procedure:TACE TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated .
OTHER	Sorafenib in combination with TACE	Drug: Sorafenib All patients will receive Sorafenib (800 mg/day) p.o. beginning one week after the first TACE and every day thereafter until patient death or premature withdrawal from study. Procedure: TACE TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated .

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-05-01
• Completion: 2015-05-01
• First posted: 2012-03-16
• Last updated: 2012-04-25

Locations

1 site across 1 country: China