Condition category
Cancer
Date applied
10/01/2009
Date assigned
15/05/2009
Last edited
15/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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. Child–Pugh 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

http://www.shdsyy.com.cn

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes