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

NCT00834158 | Completed DMC

• 1 other identifier: EHBH-RCT-2008-006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Hepatitis B; Transarterial chemoembolization (TACE); Portal vein embolization (PVE); Surgical resection; Disease-free survival; Overall survival

Outcome Measures

Primary Outcomes (1)

• the rate of tumor resection after intervention

  1 to 2 months

Secondary Outcomes (1)

• rate of survival

  1, 3, 5 year

Study Arms (2)

TACE

ACTIVE COMPARATOR

perform TACE only

Procedure: TACE

TACE+PVE

EXPERIMENTAL

perform TACE and PVE sequentially

Procedure: TACE; Procedure: PVE

Interventions

TACE PROCEDURE

1 time

Also known as: transaterial chemoemblization

TACE; TACE+PVE

PVE PROCEDURE

1 time

Also known as: portal vein embolization

TACE+PVE

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hepatitis B

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis

Study Officials

• Feng Shen, MD

  Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

• First Submitted: January 31, 2009
• First Posted: February 3, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: November 1, 2010
• Last Updated: April 1, 2016

Record last verified: 2016-03

Locations

CN (1)