TACE and Adefovir Compared With Transarterial Chemoembolization (TACE) Alone for Hepatitis B Virus (HBV)-Related Unresectable Hepatocellular Carcinoma (HCC)
TACE
Combination Therapy With TACE and Adefovir Compared With TACE Alone for HBV-related Unresectable Hepatocellular Carcinoma
1 other identifier
interventional
216
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2009
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 14, 2009
CompletedFirst Posted
Study publicly available on registry
August 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedAugust 17, 2009
August 1, 2009
3 years
August 14, 2009
August 14, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the progression free survival (PFS)
3 months
Secondary Outcomes (1)
the rate of overall survival
1, 3, 5 years
Study Arms (2)
TACE
PLACEBO COMPARATORAn 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.
TACE+adefovir
EXPERIMENTALpatients received adefovir, at a dose of 10 mg daily after TACE treatment, for 48 weeks
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Fourth Affiliated Hospital of Haerbin Medical University
Ha'er'bin, Heilongjiang, 150001, China
Shanghai 10th Hospital of Tongji University
Shanghai, Shanghai Municipality, 200025, China
Related Publications (1)
Li M, Lu C, Cheng J, Zhang J, Cao C, Xu J, Xu J, Pan H, Zhong B, Tucker S, Wang D. Combination therapy with transarterial chemoembolization and interferon-alpha compared with transarterial chemoembolization alone for hepatitis B virus related unresectable hepatocellular carcinoma. J Gastroenterol Hepatol. 2009 Aug;24(8):1437-44. doi: 10.1111/j.1440-1746.2009.05863.x. Epub 2009 May 28.
PMID: 19486255BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Maoquan Li, MD, PhD
Interventional Radiology Research Group, Shanghai Radiology Society
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 14, 2009
First Posted
August 17, 2009
Study Start
August 1, 2009
Primary Completion
August 1, 2012
Study Completion
August 1, 2015
Last Updated
August 17, 2009
Record last verified: 2009-08