NCT01605734

TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma

Phase II Trail of TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

TACE is widely used in patients with unresectable HCC. However, it is a non-curative approach; thus ,strategies to further improve the survival of these patients are needed. Sorafenib is regarded as standard treatment for advanced HCC. It is the first systemic therapy to demonstrate a significant survival benefit in HCC patients.The hypothesis is that the combination of TACE with sorafenib could improve the survival of patients with unresectable HCC.

Conditions

• PHENYTOIN/SORAFENIB [VA Drug Interaction]
• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
PROCEDURE	TACE	After obtaining arterial access,a diagnostic visceral arteriogram will be performed to demonstrate arterial supply to the tumor and the presence of variant arterial anatomy.After having positioned the catheter within the artery feeding tumor,the chemoembolization mixture will be infused into th e artery until stagnant flow is observed.
DRUG	sorafenib combined with TACE	All patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-12-01
• Completion: 2015-12-01
• First posted: 2012-05-25
• Last updated: 2012-05-25

Locations

5 sites across 1 country: China