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

March 13, 2016 updated by: Xinyu Bi, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Bei jing, China, 100026
        • Recruiting
        • Cancer Hospital and Institute, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sorafenib group
sorafenib group patients will accept sorafenib therapy for one year（400 mg bid,orally).
Drug: Sorafenib
sorafenib group patients will accept sorafenib therapy for one year（400 mg bid,orally).
Experimental: TACE group
TACE group patients will accept TACE therapy once at a month after resection.
Procedure: TACE
TACE group patients will accept TACE therapy once at a month after resection.
No Intervention: control group
Control group patients will not accept any intervention,except necessary supportive treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
recurrence-free survival
Time Frame: 36 month
36 month

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 36 month
36 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Study Director: Xinyu Bi, Doctor, Cancer Hospital and Institute, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

August 29, 2015

First Submitted That Met QC Criteria

August 29, 2015

First Posted (Estimate)

September 1, 2015

Study Record Updates

Last Update Posted (Estimate)

March 15, 2016

Last Update Submitted That Met QC Criteria

March 13, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-GI-077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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