NCT02537158

Sorafenib and TACE as Adjuvant Therapy for MVI in HCC Patients After Radical Resection

Sorafenib and TACE as Adjuvant Therapy for MVI in HCC Patients After Radical Resection:a Non-randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective non-randomized controlled study. The purpose of this study is to evaluate the validity and safety of sorafenib and transcatheter arterial chemoembolization (TACE) for microvascular invasion (MVI) in hepatocellular carcinoma (HCC) patients after radical surgery.

Detailed description

HCC is the sixth most common malignancy worldwide.Selected patients with HCC are candidates for potentially curative therapy, such as hepatic resection and liver transplantation. Nevertheless,tumor recurrence is 70 % at 5 years after resection and 15-30 % after liver transplantation,leading to tumor-related death.MVI is currently one of the most critical factors predictive of HCC recurrence.There are no approved effective interventional measures to improve the outcome of this patients with MVI.The purpose of this study is to explore the validity and safety of sorafenib and TACE for MVI in HCC patients after radical resection.The candidates will be assigned to sorafenib group (about 30 cases),TACE group (about 30 patients) and control group (about 30 cases)，according to the willingness of the subject.All patients will be followed up for 3 years and Recurrence-free survival and overall survival will be recorded.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Sorafenib	sorafenib group patients will accept sorafenib therapy for one year（400 mg bid,orally).
PROCEDURE	TACE	TACE group patients will accept TACE therapy once at a month after resection.

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2015-09-01
• Last updated: 2016-03-15

Locations

1 site across 1 country: China