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TACE and Adefovir Compared With Transarterial Chemoembolization (TACE) Alone for Hepatitis B Virus (HBV)-Related Unresectable Hepatocellular Carcinoma (HCC) (TACE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Tongji University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00960518
First Posted: August 17, 2009
Last Update Posted: August 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Interventional Radiology Research Group, Shanghai Radiology Society
Information provided by:
Tongji University
  Purpose
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 unresectable disease, the goal of palliative treatment is to control symptoms and prolong survival. Transarterial chemoembolization (TACE) using iodized oil and chemotherapeutic agents combines the effect of targeted chemotherapy with that of ischemic necrosis induced by arterial embolization. It can be administered repeatedly and can prolong survival in patients with unresectable hypervascular HCC. The long-term prognosis, however, remains guarded because of frequent development of locoregional tumor recurrence, which, together with concomitant hepatic decompensation, is the main cause of death. Adefovir works by blocking reverse transcriptase, an enzyme that is crucial for the hepatitis B virus (HBV) to reproduce in the body. Based on these results, the investigators conducted a randomized controlled trial to test the hypothesis that adefovir treatment would reduce or postpone the recurrence rate and improve the overall survival rate in patients after TACE treatment of HBV-related unresectable HCC.

Condition Intervention Phase
Hepatitis B Virus Hepatocellular Carcinoma Drug: adefovir Procedure: TACE Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination Therapy With TACE and Adefovir Compared With TACE Alone for HBV-related Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Tongji University:

Primary Outcome Measures:
  • the progression free survival (PFS) [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • the rate of overall survival [ Time Frame: 1, 3, 5 years ]

Estimated Enrollment: 216
Study Start Date: August 2009
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: TACE
An emulsion that consisted of 50 mg of cisplatin and 10 mL of lipiodol at a volume ratio of 1:1 was injected into the blood supply artery of the tumor under fluoroscopic guidance. The injection could be slowed or discontinued if retrograde flow occurred. Embolization was subsequently performed with granules of gelatin sponge particles.
Procedure: TACE
An emulsion that consisted of 50 mg of cisplatin and 10 mL of lipiodol at a volume ratio of 1:1 was injected into the blood supply artery of the tumor under fluoroscopic guidance. The injection could be slowed or discontinued if retrograde flow occurred. Embolization was subsequently performed with granules of gelatin sponge particles.
Experimental: TACE+adefovir
patients received adefovir, at a dose of 10 mg daily after TACE treatment, for 48 weeks
Drug: adefovir
adefovir at 10 mg daily for 48 weeks

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 therapy has been established for treatment of hepatocellular carcinoma. For patients with unresectable disease, the goal of palliative treatment is to control symptoms and prolong survival. Transarterial chemoembolization (TACE) using iodized oil and chemotherapeutic agents combines the effect of targeted chemotherapy with that of ischemic necrosis induced by arterial embolization. It can be administered repeatedly and can prolong survival in patients with unresectable hypervascular HCC. The long-term prognosis, however, remains guarded because of frequent development of locoregional tumor recurrence, which, together with concomitant hepatic decompensation, is the main cause of death. Recurrence in the liver remnant may originate from metastasis from the primary tumor or multicentric new primaries in a cirrhotic liver.

Adefovir works by blocking reverse transcriptase, an enzyme that is crucial for the hepatitis B virus (HBV) to reproduce in the body. It is approved for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (primarily ALT) or histologically active disease. The main benefit of adefovir over lamivudine (the first NRTI approved for the treatment of hepatitis B) is that it takes a much longer period of time before the virus develops resistance to it. Adefovir dipivoxil contains two pivaloyloxymethyl units, making it a prodrug form of Adefovir.

Based on these results, the investigators conducted a randomized controlled trial to test the hypothesis that adefovir treatment would reduce or postpone the recurrence rate and improve the overall survival rate in patients after TACE treatment of HBV-related unresectable HCC.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960518


Contacts
Contact: Daoyuan Wang, MD +86-21-6630058 ghealth2008@gmail.com

Locations
China, Heilongjiang
The Fourth Affiliated Hospital of Haerbin Medical University Recruiting
Ha'er'bin, Heilongjiang, China, 150001
Contact: Baozhong Shen, MD    +86-451-82576888    drbaozhong.shen@gmail.com   
Principal Investigator: Baozhong Shen, MD         
China, Shanghai
Shanghai 10th Hospital of Tongji University Recruiting
Shanghai, Shanghai, China, 200025
Contact: Maoquan Li, MD, PhD    +86-21-6630058    drmaoquan.li@gmail.com   
Principal Investigator: Maoquan Li, MD, PhD         
Sponsors and Collaborators
Tongji University
Interventional Radiology Research Group, Shanghai Radiology Society
Investigators
Study Chair: Maoquan Li, MD, PhD Interventional Radiology Research Group, Shanghai Radiology Society
  More Information

Publications:
Responsible Party: Shanghai 10th Hospital, Tongji University
ClinicalTrials.gov Identifier: NCT00960518     History of Changes
Other Study ID Numbers: SHDSYY20090725
First Submitted: August 14, 2009
First Posted: August 17, 2009
Last Update Posted: August 17, 2009
Last Verified: August 2009

Keywords provided by Tongji University:
HBV-related unresectable HCC
TACE
adefovir
recurrence rate

Additional relevant MeSH terms:
Carcinoma
Hepatitis
Carcinoma, Hepatocellular
Hepatitis B
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Chlorotrianisene
Adefovir
Adefovir dipivoxil
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors