TACE and Adefovir Compared With Transarterial Chemoembolization (TACE) Alone for Hepatitis B Virus (HBV)-Related Unresectable Hepatocellular Carcinoma (HCC)
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Combination Therapy With TACE and Adefovir Compared With TACE Alone for HBV-related Unresectable Hepatocellular Carcinoma |
- the progression free survival (PFS) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- the rate of overall survival [ Time Frame: 1, 3, 5 years ] [ Designated as safety issue: Yes ]
| 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| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Daoyuan Wang, MD | +86-21-6630058 | ghealth2008@gmail.com |
| 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 | |
| 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 |
| Study First Received: | August 14, 2009 |
| Last Updated: | August 14, 2009 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Tongji University:
|
HBV-related unresectable HCC TACE adefovir recurrence rate |
Additional relevant MeSH terms:
|
Carcinoma Hepatitis Hepatitis A Hepatitis B Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Hepadnaviridae Infections DNA Virus Infections Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Adefovir Adefovir dipivoxil Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013