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Completed

NCT Number: NCT00834158

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TACE

Procedure

1 time

Other names: transaterial chemoemblization

PVE

Procedure

1 time

Other names: portal vein embolization

Primary outcomes

  1. the rate of tumor resection after intervention

    Time frame: 1 to 2 months

Secondary outcomes

  1. rate of survival

    Time frame: 1, 3, 5 year

Sponsors and collaborators

Lead sponsor

Eastern Hepatobiliary Surgery Hospital

Other

Registry information

Official study title

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

Acronym: TACEPVE

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Feb 3, 2009
Registry last updated
Apr 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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