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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02537158
Study type Interventional
Source Chinese Academy of Medical Sciences
Contact Xinyu Bi, Doctor
Phone 86-13911792177
Email beexy1971@163.com
Status Recruiting
Phase N/A
Start date August 2015
Completion date July 2018
View Details
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