Efficacy of Sequential TACE and PVE on the Resectability of Hepatitis B Related HCC (TACEPVE)

March 30, 2016 updated by: ShenFeng, Eastern Hepatobiliary Surgery Hospital

Efficacy of Sequential Arterial and Portal Vein Embolizations on Increasing the Resectability of Hepatitis B Related Primary Hepatocellular Carcinoma

A primary hepatocellular carcinoma (HCC) is generally regarded as unresectable if the future liver remnant (FLR)≤40％ of total liver volume in patient with underlying liver disease, such as hepatitis B. In China, TACE is the most common treatment for these unresectable HCC. Recently, PVE has been employed to enlarge the FLR of the patients so as to increase the resectability and surgical safety of major hepatectomies. In order to shut the arterio-portal shunt in the liver and control the tumor progress TACE sometimes is performed before PVE. In this study we design a randomized control trial to investigate the efficacy of sequential TACE and PVE on increasing the resectability of hepatitis B related HCC compared with TACE alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In China, primary hepatocellular carcinoma (HCC) is mostly a hepatitis B related disease. The liver function of these patients has been damaged, which often limit the execution of major hepatectomy. A tumor is generally regarded as unresectable if the future liver remnant (FLR)≤40％ of total liver volume in patient with underlying liver disease. In China, TACE is the most common treatment for these unresectable HCC. TACE can slow down tumor progress but has little effect on enlarging FLR. Recently, PVE has been employed to enlarge the FLR of the patients so as to increase the resectability and surgical safety of major hepatectomies. But the intrahepatic arterioportal shunt and the tumor progress has decreased the effect of PVE. In order to shut the arterioportal shunt and control the tumor progress TACE sometimes is performed before PVE. In this study we design a randomized control trial to investigate the efficacy of sequential TACE and PVE on increasing the resectability of hepatitis B related HCC compared with TACE alone.

Study Type

Interventional

Enrollment (Actual)

20

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
      • Shanghai, China, 200438
        • Eastern Hepatobiliary Surgery Hospital

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

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age:20-65years old;
  2. with a clinical diagnosis of primary liver cancer, with HBsAg positive,without any therapy for tumor;
  3. single lesion with a diameter >6.5cm,or multiple lesions locating within half liver or adjacent three lobe;
  4. estimated liver remnant volume ≤40%
  5. with a liver function of Child-Pugh class A,and ALT≤80IU/l.

Exclusion criteria:

  1. reject to attend；
  2. portal vein trunk has been compressed by tumor;
  3. diffuse type cancer or with extensive cancer thrombus in main branches of PV,HV,IVC or bile duct;
  4. with extrahepatic metastasis;
  5. with obvious portal hypertension (with moderate to severe varix in esophagus and/or gastric fundus, enlarged spleen,WBC<4×109／L, PLT<80×109／L)
  6. with diabetes
  7. allergy to iodine

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: TACE
perform TACE only
Procedure: TACE
1 time
Other Names:
  • transaterial chemoemblization
EXPERIMENTAL: TACE+PVE
perform TACE and PVE sequentially
Procedure: TACE
1 time
Other Names:
  • transaterial chemoemblization
Procedure: PVE
1 time
Other Names:
  • portal vein embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the rate of tumor resection after intervention
Time Frame: 1 to 2 months
1 to 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
rate of survival
Time Frame: 1, 3, 5 year
1, 3, 5 year

Collaborators and Investigators

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

Sponsor

Eastern Hepatobiliary Surgery Hospital

Investigators

  • Study Chair: Feng Shen, MD, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

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

January 1, 2009

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

January 31, 2009

First Submitted That Met QC Criteria

January 31, 2009

First Posted (ESTIMATE)

February 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 1, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHBH-RCT-2008-006

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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