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

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: TACE; Drug: Sorafenib

• Registration Number: NCT02537158
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief 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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-29
• Study First Submitted QC: 2015-08-29
• Study First Posted: 2015-09-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-13
• Last Update Posted: 2016-03-15
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 18-75 years of age;
• The liver tumor has been radically resected;
• Postoperative pathology proved to be hepatocellular carcinoma with negative margin and microvascular invasion;
• Imaging evaluations(CT/MRI) were performed at 1 month after the resection and no area of enhancement was seen;
• Child-Pugh A;
• Eastern Cooperative Oncology Group(ECOG) body condition score (PS) 0-1;
• Then patients understand and voluntarily signed a written informed consent;

Exclusion Criteria

• Recurrent HCC;
• pathology-proved multifocal HCC or HCC with satellite nodules;
• Tumor thrombus in portal vein or inferior vena cava trunk;
• Patients with extrahepatic metastasis found by radiologic or pathologic examination;
• severe dysfunction of the heart, kidney, or other organs.The patients cannot tolerate TACE or sorafenib after general assessment of the situation;
• Enrolled in other clinical study at the same time;
• Previously treated with other antitumor treatments except the resection;
• The researchers believe that the patient does not fit this study;
• Pregnant or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
recurrence-free survival	36 month

Secondary Outcome Measures

Name	Time	Method
overall survival	36 month

Trial Locations

Locations (1)

Cancer Hospital and Institute, Chinese Academy of Medical Sciences; 🇨🇳 Bei jing, China