Status:
UNKNOWN
TACE and Adefovir Compared With Transarterial Chemoembolization (TACE) Alone for Hepatitis B Virus (HBV)-Related Unresectable Hepatocellular Carcinoma (HCC)
Lead Sponsor:
Tongji University
Collaborating Sponsors:
Interventional Radiology Research Group, Shanghai Radiology Society
Conditions:
Hepatitis B Virus
Hepatocellular Carcinoma
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies in China, and approximately 90% of the patients with HCC are also infected with hepatitis B virus (HBV). For patients with unre...
Detailed Description
Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies in China, and approximately 90% of the patients with HCC are also infected with hepatitis B virus (HBV). Until now, no standard...
Eligibility Criteria
Inclusion
- age:20-75 years old
- with a clinical diagnosis of primary liver cancer, with HBsAg positive,without any therapy for tumor
- single lesion with a diameter \>6.5 cm,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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2015
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT00960518
Start Date
August 1 2009
End Date
August 1 2015
Last Update
August 17 2009
Active Locations (2)
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1
The Fourth Affiliated Hospital of Haerbin Medical University
Ha'er'bin, Heilongjiang, China, 150001
2
Shanghai 10th Hospital of Tongji University
Shanghai, Shanghai Municipality, China, 200025