Know Cancer

forgot password

Combination Therapy With TACE and Adefovir Compared With TACE Alone for HBV-related Unresectable Hepatocellular Carcinoma

Phase 2
20 Years
75 Years
Open (Enrolling)
Hepatitis B Virus, Hepatocellular Carcinoma

Thank you

Trial Information

Combination Therapy With TACE and Adefovir Compared With TACE Alone for HBV-related Unresectable Hepatocellular Carcinoma

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

the progression free survival (PFS)

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Maoquan Li, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Interventional Radiology Research Group, Shanghai Radiology Society


China: Food and Drug Administration

Study ID:




Start Date:

August 2009

Completion Date:

August 2015

Related Keywords:

  • Hepatitis B Virus
  • Hepatocellular Carcinoma
  • HBV-related unresectable HCC
  • TACE
  • adefovir
  • recurrence rate
  • Carcinoma
  • Hepatitis
  • Hepatitis A
  • Hepatitis B
  • Carcinoma, Hepatocellular