NCT02529761

TACE With or Without Sorafenib in Intermediate Stage Hepatocellular Carcinoma

Transarterial Chemoembolization (TACE) With or Without Sorafenib in Intermediate Stage Hepatocellular Carcinoma: a Multicenter Prospective Nonrandomized Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Air Force Military Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter prospective nonrandomized study is to evaluate the efficacy of TACE combined with sorafenib compared with TACE monotherapy in term of overall survival in intermediate-stage HCC.

Detailed description

Sorafenib, a multikinase inhibitor, has been successfully applied for solid tumors such as renal cancer and HCC. According to the Barcelona Clinic Liver Cancer (BCLC) staging classification, transarterial chemoembolization (TACE) has been recommended as a first line-therapy for patients at intermediate stage - BCLC B class (multinodular asymptomatic tumors without an invasive pattern). Because sorafenib may improve the efficacy of locoregional therapy by decreasing post-TACE angiogenesis, sorafenib in combination with TACE has attracted considerable attention as a promising therapy

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Sorafenib	Sorafenib will be supplied as 200 mg tablets. All subjects will take two tablets of sorafenib (200 mg tablets) twice daily (each morning and evening).
PROCEDURE	TACE	The first treatment of TACE should be completed within 3-7 days after the administration of sorafenib started. In all cases, TACE consists of an injection containing a mixture of chemotherapeutic agents and lipiodol followed by embolization with polyvinyl alcohol (PVA) particles until complete stasis was achieved in the tumor-feeding vessels.Tumor-feeding vessels should be selected/superselected whenever possible. TACE will be repeated "on demand" depending on the radiological response.

Timeline

• Start date: 2015-08-01
• Primary completion: 2021-08-01
• Completion: 2021-10-01
• First posted: 2015-08-20
• Last updated: 2019-08-01

Locations

1 site across 1 country: China