Know Cancer

forgot password

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

20 Years
65 Years
Open (Enrolling)
Hepatocellular Carcinoma

Thank you

Trial Information

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

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

the rate of tumor resection after intervention

Outcome Time Frame:

1 to 2 months

Safety Issue:


Principal Investigator

Feng Shen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University


China: Ministry of Health

Study ID:




Start Date:

January 2009

Completion Date:

November 2010

Related Keywords:

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