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

Controlled study of hepatitis B virus level alteration in hepatocellular carcinoma: monotherapy with transcatheter arterial chemoembolisation versus double therapy with transcatheter arterial chemoembolisation and interferon-alpha: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85736336

Enrollment

116

Registered

2009-05-15

Start date

2008-12-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B virus related hepatocellular carcinoma Cancer Malignant neoplasm of liver and intrahepatic bile ducts

Interventions

All included patients will be divided into two groups by randomisation. One group will receive double therapy with TACE and IFN-a, while the other group will receive monotherapy with TACE as control.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. HBV reactivation, defined as a greater than 10-fold increase in serum HBV-DNA compared with the baseline level 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 3. Disease progress, according to the Response Evaluation Criteria in Solid Tumors (RECIST) standard 4. Patient death The outcomes above will be measured every month after the end of therapy until 6 months.	—

Measure

Time frame

1. HBV reactivation, defined as a greater than 10-fold increase in serum HBV-DNA compared with the baseline level 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 3. Disease progress, according to the Response Evaluation Criteria in Solid Tumors (RECIST) standard 4. Patient death The outcomes above will be measured every month after the end of therapy until 6 months.

—

Secondary

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

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026