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

ISRCTN	ISRCTN85736336
DOI	https://doi.org/10.1186/ISRCTN85736336
Secondary identifying numbers	N/A

Submission date: 10/01/2009
Registration date: 15/05/2009
Last edited: 15/05/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Maoquan Li
Scientific

Interventional Department
Affiliated 10th People's Hospital of Tongji University
No. 301 Middle Yanchang Road
Shanghai
200072
China

Email	cjr.limaoquan@vip.163.com

Study information

Study design	Randomised controlled non-blinded single-centre study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Ethics Committee of the Affiliated 10th People's Hospital, Tongji University, approved in October 2008 (ref: 08-10-5).
Health condition(s) or problem(s) studied	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
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 study start date	01/12/2008
Completion date	01/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	116
Key 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
Key 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
Date of first enrolment	01/12/2008
Date of final enrolment	01/09/2009

Locations

Countries of recruitment

China

Study participating centre

Interventional Department

Shanghai
200072
China

Sponsor information

Affiliated 10th People's Hospital of Tongji University (China)
Hospital/treatment centre

No. 301 Middle Yanchang Road
Shanghai
200072
China

Website	http://www.shdsyy.com.cn
"ROR"	https://ror.org/03vjkf643

Funders

Funder type

Hospital/treatment centre

Affiliated 10th People's Hospital of Tongji University (China)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan