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

Study Overview
=================
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.

Detailed 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.

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

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: TACE
* Procedure: PVE


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TACE<br>perform TACE only | Procedure: TACE<br>* 1 time<br>* Other names: transaterial chemoemblization;|
| Experimental: TACE+PVE<br>perform TACE and PVE sequentially | Procedure: TACE<br>* 1 time<br>* Other names: transaterial chemoemblization;Procedure: PVE<br>* 1 time<br>* Other names: portal vein embolization;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of tumor resection after intervention |  | 1 to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of survival |  | 1, 3, 5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular Carcinoma, Hepatitis B, Transarterial chemoembolization (TACE), Portal vein embolization (PVE), Surgical resection, Disease-free survival, Overall survival