Efficacy of Sequential TACE and PVE on the Resectability of Hepatitis B Related HCC - Full Text View

Sponsored by:	Eastern Hepatobiliary Surgery Hospital
Information provided by:	Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:	NCT00834158

Purpose

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.

Condition	Intervention
Hepatocellular Carcinoma	Procedure: TACE Procedure: PVE

MedlinePlus related topics: Cancer Hepatitis Hepatitis B Surgery

Drug Information available for: Hepatitis B Vaccines Chlorotrianisene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy of Sequential Arterial and Portal Vein Embolizations on Increasing the Resectability of Hepatitis B Related Primary Hepatocellular Carcinoma

Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:

the rate of tumor resection after intervention [ Time Frame: 1 to 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

rate of survival [ Time Frame: 1, 3, 5 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	January 2009
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
TACE: Active Comparator perform TACE only	Procedure: TACE 1 time
TACE+PVE: Experimental perform TACE and PVE sequentially	Procedure: TACE 1 time Procedure: PVE 1 time

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.

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion criteria:

reject to attend；
portal vein trunk has been compressed by tumor;
diffuse type cancer or with extensive cancer thrombus in main branches of PV,HV,IVC or bile duct;
with extrahepatic metastasis;
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)
with diabetes
allergy to iodine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834158

Contacts

Contact: Yi Wang, MD

+86 21 81870791

wangyi-ehbh@163.com

Locations

China
Eastern Hepatobiliary Surgery Hospital	Recruiting
Shanghai, China, 200438
Contact: Yi Wang, MD +86 21 81870791 wangyi-ehbh@163.com
Principal Investigator: Yi Wang, MD

Sponsors and Collaborators

Eastern Hepatobiliary Surgery Hospital

Investigators

Study Chair:

Feng Shen, MD

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

More Information

No publications provided

Responsible Party:	Department of Hepatic SurgeryⅡ, Eastern Hepatobiliary Surgery Hospital ( Yi Wang )
Study ID Numbers:	EHBH-RCT-2008-006
Study First Received:	January 31, 2009
Last Updated:	February 22, 2009
ClinicalTrials.gov Identifier:	NCT00834158 History of Changes
Health Authority:	China: Ministry of Health

Keywords provided by Eastern Hepatobiliary Surgery Hospital:

Hepatocellular Carcinoma
Hepatitis B
Transarterial chemoembolization (TACE)
Portal vein embolization (PVE)

Surgical resection
Disease-free survival
Overall survival

Study placed in the following topic categories:

Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Hepatitis, Viral, Human
Carcinoma
Hepatitis
Virus Diseases
Liver Neoplasms

Digestive System Diseases
Hepatitis B
Gastrointestinal Neoplasms
DNA Virus Infections
Hepatocellular Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Liver Diseases
Digestive System Neoplasms
Neoplasms by Histologic Type
Carcinoma, Hepatocellular
Hepatitis, Viral, Human
Hepadnaviridae Infections
Carcinoma
Liver Neoplasms
Hepatitis

Virus Diseases
Neoplasms
Neoplasms by Site
Digestive System Diseases
Hepatitis B
DNA Virus Infections
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009