NCT00768157

Brief Summary

Most hepatocellular carcinomas are associated with hepatitis B virus, it is hypothesized that anti-viral treatment may be helpful in treating HBV-related hepatocellular carcinoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4 hepatocellular-carcinoma

Timeline
Completed

Started Apr 2007

Typical duration for phase_4 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

February 9, 2009

Status Verified

February 1, 2009

Enrollment Period

2.3 years

First QC Date

October 6, 2008

Last Update Submit

February 6, 2009

Conditions

Hepatocellular CarcinomaHepatitis B VirusRecurrence

Keywords

hepatocellular carcinomahepatitis B virussurgeryanti-virusrecurrence

Outcome Measures

Primary Outcomes (1)

  • Overall survivals

    2,3,5years

Secondary Outcomes (1)

  • Recurrence rate

    2,3,5years

Study Arms (2)

antiviral group

EXPERIMENTAL

Drug: antiviral treatment(lamivudine or entecavir) after the Procedure/Surgery (radical resection of HBV-related HCC)

Drug: antiviral treatment (lamivudine or entecavir)Procedure: radical resection of HBV-related HCC

control group

ACTIVE COMPARATOR

Procedure/Surgery (radical resection of HBV-related HCC) without Drug of antiviral treatment - close observation without antiviral treatment

Procedure: radical resection of HBV-related HCC

Interventions

antiviral treatment (lamivudine or entecavir)DRUG

antiviral treatment (lamivudine 100mg per day or entecavir 0.5mg per day)

antiviral group
radical resection of HBV-related HCCPROCEDURE

Procedure/Surgery - radical resection of HBV-related HCC

antiviral groupcontrol group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who did not receive antiviral therapy prior to the resection of hepatocellular carcinoma
  • patients who underwent radical resection of HCC, and 1 month after surgery,dynamic computed tomography showed on lesion in the liver and no signs of extrahepatic metastasis.
  • hepatitis B surface antigen should be positive before surgery HBV-DNA level between 100000 copies/ml and 10000000copies/ml anti-HCV negative

You may not qualify if:

  • previous history of antiviral therapy
  • a baseline serum alanine aminotransferase level 2.5 times the ULN or higher
  • positive for anti-HCV or anti-HIV
  • Child-Pugh classification B or C after surgery
  • preexisting evidence of hepatic decompensation, including encephalopathy,ascites,a bilirubin level more than 2 times the ULN, or a prolonged prothrombin time of more than 3 seconds
  • signs showing recurrence or metastasis oen month after surgery
  • underlying cardiac or renal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiang-Ming Lao

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (7)

  • Jang JW, Choi JY, Bae SH, Yoon SK, Chang UI, Kim CW, Cho SH, Han JY, Lee YS. A randomized controlled study of preemptive lamivudine in patients receiving transarterial chemo-lipiodolization. Hepatology. 2006 Feb;43(2):233-40. doi: 10.1002/hep.21024.

    PMID: 16440357BACKGROUND

  • Jang JW, Choi JY, Bae SH, Yoon SK, Woo HY, Chang UI, Kim CW, Nam SW, Cho SH, Yang JM, Lee CD. The impact of hepatitis B viral load on recurrence after complete necrosis in patients with hepatocellular carcinoma who receive transarterial chemolipiodolization: implications for viral suppression to reduce the risk of cancer recurrence. Cancer. 2007 Oct 15;110(8):1760-7. doi: 10.1002/cncr.22984.

    PMID: 17724708BACKGROUND

  • Jang JW, Choi JY, Bae SH, Kim CW, Yoon SK, Cho SH, Yang JM, Ahn BM, Lee CD, Lee YS, Chung KW, Sun HS. Transarterial chemo-lipiodolization can reactivate hepatitis B virus replication in patients with hepatocellular carcinoma. J Hepatol. 2004 Sep;41(3):427-35. doi: 10.1016/j.jhep.2004.05.014.

    PMID: 15336446BACKGROUND

  • Poon RT. Significance of viral status on prognosis after resection of hepatitis B virus related hepatocellular carcinoma. J Hepatol. 2007 Nov;47(5):630-1. doi: 10.1016/j.jhep.2007.08.007. Epub 2007 Sep 5. No abstract available.

    PMID: 17881079BACKGROUND

  • Sun HC, Zhang W, Qin LX, Zhang BH, Ye QH, Wang L, Ren N, Zhuang PY, Zhu XD, Fan J, Tang ZY. Positive serum hepatitis B e antigen is associated with higher risk of early recurrence and poorer survival in patients after curative resection of hepatitis B-related hepatocellular carcinoma. J Hepatol. 2007 Nov;47(5):684-90. doi: 10.1016/j.jhep.2007.06.019. Epub 2007 Aug 13.

    PMID: 17854945BACKGROUND

  • Kubo S, Hirohashi K, Yamazaki O, Matsuyama M, Tanaka H, Horii K, Shuto T, Yamamoto T, Kawai S, Wakasa K, Nishiguchi S, Kinoshita H. Effect of the presence of hepatitis B e antigen on prognosis after liver resection for hepatocellular carcinoma in patients with chronic hepatitis B. World J Surg. 2002 May;26(5):555-60. doi: 10.1007/s00268-001-0267-1. Epub 2002 Feb 19.

    PMID: 12098045BACKGROUND

  • Kubo S, Nishiguchi S, Hamba H, Hirohashi K, Tanaka H, Shuto T, Kinoshita H, Kuroki T. Reactivation of viral replication after liver resection in patients infected with hepatitis B virus. Ann Surg. 2001 Jan;233(1):139-45. doi: 10.1097/00000658-200101000-00020.

    PMID: 11141236BACKGROUND

MeSH Terms

Conditions

Carcinoma, HepatocellularHepatitis BRecurrence

Interventions

Lamivudineentecavir

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Study Officials

  • Jin-Qing LI, Ph.D

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Min-Shan CHEN, Ph.D

    Sun Yat-sen University

    STUDY DIRECTOR

  • Xiao-Jun LIN, Ph.D

    Sun Yat-sen University

    STUDY DIRECTOR

  • Xiang-Ming LAO, Ph.D

    Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Xiang-Ming LAO, Ph.D

CONTACT

8620-87343115laoxming@mail.sysu.edu.cn

Xiao-Jun LIN, Ph.D

CONTACT

8620-87343017sumslxm@sohu.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2008

First Posted

October 7, 2008

Study Start

April 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2010

Last Updated

February 9, 2009

Record last verified: 2009-02

Locations

CN(1)