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

Naval Military Medical University (Second Military Medical University)

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: PVE; Procedure: TACE

Study type: Interventional

Funder types: Other

Identifiers

NCT00834158

EHBH-RCT-2008-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

TACE

Active Comparator group

Description:

perform TACE only

Treatment:

Procedure: TACE

TACE+PVE

Experimental group

Description:

perform TACE and PVE sequentially

Treatment:

Procedure: TACE

Procedure: PVE