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

• Status: Unknown status
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tongji University
• Collaborator: Interventional Radiology Research Group, Shanghai Radiology Society
• Treatments: Adefovir; Adefovir dipivoxil; Chlorotrianisene

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