Controlled study of hepatitis B virus level alteration in hepatocellular carcinoma while treating with transcatheter arterial chemoembolisation alone or in combination with interferon-alpha

Completed

• Conditions: Hepatitis B virus related hepatocellular carcinoma; Malignant neoplasm of liver and intrahepatic bile ducts; Cancer

• Registration Number: ISRCTN85736336
• Lead Sponsor: Affiliated 10th People's Hospital of Tongji University (China)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-15
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

1. Image or pathologically diagnosed HCC
2. Newly diagnosed HCC
3. Unresectable HCC
4. Positive serum HBS-Ag and HBe-Ag
5. Child-Pugh scale A and B
6. Older than 20 years, either sex
7. Patients without jaundice

Exclusion Criteria

1. Previous history of antiviral therapy
2. Baseline serum alanine aminotransferase (ALT) level 2.5 times the upper limit of normal or higher
3. Serum HBV DNA level greater than 107 copies/mL
4. Main portal vein thrombosis
5. Underlying cardiac or renal diseases
6. Positive tests for antibody to hepatitis C virus or human immunodeficiency virus
7. Child?Pugh classification C
8. Pre-existing evidence of hepatic decompensation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. HBV reactivation, defined as a greater than 10-fold increase in serum HBV-DNA compared with the baseline level <br>2. Hepatitis due to HBV reactivation, defined as a threefold or greater increase in serum ALT to a level that exceeded 100 IU/L (reference range less than 33 IU/L) in patients with HBV reactivation in the absence of clinical features of tumour progression, hepatotoxic drugs, treatment-related hepatic damage, or other systemic infections <br>3. Disease progress, according to the Response Evaluation Criteria in Solid Tumors (RECIST) standard <br>4. Patient death <br><br>The outcomes above will be measured every month after the end of therapy until 6 months.

Secondary Outcome Measures

Name	Time	Method
Severe complications: unendurable fever, hepatic decompensation, measured every month after the end of therapy until 6 months.