Contact information
Type
Scientific
Primary contact
Dr Maoquan Li
ORCID ID
Contact details
Interventional Department
Affiliated 10th People's Hospital of Tongji University
No. 301 Middle Yanchang Road
Shanghai
200072
China
cjr.limaoquan@vip.163.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
Study hypothesis
Hepatitis B virus (HBV) has been proved as one principal inducer of hepatiocellular carcinoma (HCC) by epidemiology study and animal experiment. And for many unresectable HCC, transcatheter arterial chemoembolism (TACE) is the most effective way to relieve the disease and elongate life. However, some studies have revealed that TACE may reactivate HBV replication and result in worse prognosis in HCC patients.
Some evidences show that interferon-alpha (IFN-a) can reduce HBV level effectively and safely. In addition, IFN-a has also been proved a worthful therapy to HBV-related HCC with postponed recurrence and prolonged life time. We assume that at the same time of TACE treatment, administration of IFN-a may suppress the reactivation of HBV replication. To test our assumption, we designed a randomised controlled study in HCC patients with positive hepatitis B surface antigen (HBS-Ag) and hepatitis B e antigen (HBe-Ag) to evaluate the efficacy of HBV inhibition and survival by double therapy with TACE and IFN-a versus monotherapy with TACE.
Ethics approval
Ethics Committee of the Affiliated 10th People's Hospital, Tongji University, approved in October 2008 (ref: 08-10-5).
Study design
Randomised controlled non-blinded single-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Hepatitis B virus related hepatocellular carcinoma
Intervention
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.
A 0.2% emulsion of epirubicin mixed with lipiodine (GUERBET™) is used for TACE in both groups. IFN-a is administered at a dosage of 60 ug every other day for a duration of 6 months. The frequency and total duration of TACE therapy for each group is once per month and 3 times in total. Follow-up for HBV-DNA level, survival and progress free survival (PFS) will last for 6 months.
Intervention type
Other
Phase
Phase IV
Drug names
Primary outcome measure
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 outcome measures
Severe complications: unendurable fever, hepatic decompensation, measured every month after the end of therapy until 6 months.
Overall trial start date
01/12/2008
Overall trial end date
01/09/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
116
Participant 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. ChildPugh classification C
8. Pre-existing evidence of hepatic decompensation
Recruitment start date
01/12/2008
Recruitment end date
01/09/2009
Locations
Countries of recruitment
China
Trial participating centre
Interventional Department
Shanghai
200072
China
Sponsor information
Organisation
Affiliated 10th People's Hospital of Tongji University (China)
Sponsor details
No. 301 Middle Yanchang Road
Shanghai
200072
China
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Affiliated 10th People's Hospital of Tongji University (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list