Efficacy of Sequential TACE and PVE on the Resectability of Hepatitis B Related HCC (TACEPVE)
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TACE
PVE
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Hepatitis B, Transarterial chemoembolization (TACE), Portal vein embolization (PVE), Surgical resection, Disease-free survival, Overall survival
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
Sites / Locations
- Eastern Hepatobiliary Surgery Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TACE
TACE+PVE
Arm Description
perform TACE only
perform TACE and PVE sequentially
Outcomes
Primary Outcome Measures
the rate of tumor resection after intervention
Secondary Outcome Measures
rate of survival
Full Information
NCT ID
NCT00834158
First Posted
January 31, 2009
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00834158
Brief Title
Efficacy of Sequential TACE and PVE on the Resectability of Hepatitis B Related HCC
Acronym
TACEPVE
Official Title
Efficacy of Sequential Arterial and Portal Vein Embolizations on Increasing the Resectability of Hepatitis B Related Primary Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, Hepatitis B, Transarterial chemoembolization (TACE), Portal vein embolization (PVE), Surgical resection, Disease-free survival, Overall survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TACE
Arm Type
Active Comparator
Arm Description
perform TACE only
Arm Title
TACE+PVE
Arm Type
Experimental
Arm Description
perform TACE and PVE sequentially
Intervention Type
Procedure
Intervention Name(s)
TACE
Other Intervention Name(s)
transaterial chemoemblization
Intervention Description
1 time
Intervention Type
Procedure
Intervention Name(s)
PVE
Other Intervention Name(s)
portal vein embolization
Intervention Description
1 time
Primary Outcome Measure Information:
Title
the rate of tumor resection after intervention
Time Frame
1 to 2 months
Secondary Outcome Measure Information:
Title
rate of survival
Time Frame
1, 3, 5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Shen, MD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
ZIP/Postal Code
200438
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Sequential TACE and PVE on the Resectability of Hepatitis B Related HCC
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