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

Hepatocellular Carcinoma Clinical Trial

— TACEPVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00834158
• Other study ID #: EHBH-RCT-2008-006
• Status: Completed
• Phase: N/A
• First received: January 31, 2009
• Last updated: March 30, 2016
• Start date: January 2009
• Est. completion date: November 2010

Study information

• Verified date: March 2016
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatitis B
• Hepatocellular Carcinoma

Intervention

Procedure:
• TACE
1 time
• PVE
1 time

Locations

Country	Name	City	State
China	Eastern Hepatobiliary Surgery Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of tumor resection after intervention		1 to 2 months	Yes
Secondary	rate of survival		1, 3, 5 year	Yes