Hepatocellular CarcinomaPhase 4NCT00768157
Efficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma
A Phase 4 study testing antiviral treatment (lamivudine or entecavir) and radical resection of HBV-related HCC in people with Hepatocellular Carcinoma and Hepatitis B Virus, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatitis B Virus, Recurrence
- What is being tested?
- antiviral treatment (lamivudine or entecavir) and radical resection of HBV-related HCC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2007to Aug 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiang-Ming Lao
Guangzhou, Guangdong, 510060
Xiang-Ming LAO, Ph.D, 8620-87343017, laoxming@mail.sysu.edu.cn
Jin-Qing LI, Ph.D
About this study
Official title: Efficacy of Antiviral Therapy With Lamivudine or Entecavir After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma
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.
Read the detailed description
As we know, recurrence and metastasis could happen in hepatocellular carcinoma even after radical resection.One reason is that virus hepatitis B could be one factor contributing to the carcinogenesis of hepatocellular carcinoma.To investigated whether anti-viral therapy could improve the efficacy of radical resection of hepatitis B virus (HBV)-related hepatocellular carcinoma(HCC),we planed to conduct this clinical trial.
- Conditions
- Hepatocellular Carcinoma, Hepatitis B Virus, Recurrence
- Being tested
- antiviral treatment (lamivudine or entecavir), radical resection of HBV-related HCC
- Keywords
- hepatocellular carcinoma, hepatitis B virus, surgery, anti-virus, recurrence
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis B, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiviral treatment (lamivudine or entecavir)Drug
antiviral treatment (lamivudine 100mg per day or entecavir 0.5mg per day)
radical resection of HBV-related HCCProcedure or surgery
Procedure/Surgery - radical resection of HBV-related HCC
| Study group | Role | What they receive |
|---|---|---|
| antiviral group | Experimental | Drug: antiviral treatment(lamivudine or entecavir) after the Procedure/Surgery (radical resection of HBV-related HCC) Receives: 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 Receives: Procedure: radical resection of HBV-related HCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survivals
Measured: 2,3,5years
Secondary outcomes (1)
Recurrence rate
Measured: 2,3,5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startApr 2007
- Primary completionAug 2009 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Jin-Qing LI, Ph.D, Principal investigator, Sun Yat-sen UniversityMin-Shan CHEN, Ph.D, Study director, Sun Yat-sen UniversityXiao-Jun LIN, Ph.D, Study director, Sun Yat-sen UniversityXiang-Ming LAO, Ph.D, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768157
- Sponsor's protocol ID
- SYSUCC-HCC004
- Status last verified
- Feb 2009
- First submitted
- 6 Oct 2008
- Last updated
- 9 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16440357Jang 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.
PubMed 17724708Jang 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.
PubMed 15336446Poon 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.
PubMed 17881079Sun 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.
PubMed 17854945Kubo 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.
PubMed 12098045Kubo 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.
PubMed 11141236
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Antiviral Therapy With Lamivudine or Entecavir After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00768157
- Acronym / sponsor ID
- SYSUCC-HCC004
- Conditions
- Hepatocellular Carcinoma, Hepatitis B Virus, Recurrence
- Keywords
- hepatocellular carcinoma, hepatitis B virus, surgery, anti-virus, recurrence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 7 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As we know, recurrence and metastasis could happen in hepatocellular carcinoma even after radical resection.One reason is that virus hepatitis B could be one factor contributing to the carcinogenesis of hepatocellular carcinoma.To investigated whether anti-viral therapy could improve the efficacy of radical resection of hepatitis B virus (HBV)-related hepatocellular carcinoma(HCC),we planed to conduct this clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antiviral group | Experimental | Drug: antiviral treatment (lamivudine or entecavir), Procedure: radical resection of HBV-related HCCDrug: antiviral treatment(lamivudine or entecavir) after the Procedure/Surgery (radical resection of HBV-related HCC) |
| control group | Active comparator | Procedure: radical resection of HBV-related HCCProcedure/Surgery (radical resection of HBV-related HCC) without Drug of antiviral treatment - close observation without antiviral treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antiviral treatment (lamivudine or entecavir)antiviral treatment (lamivudine 100mg per day or entecavir 0.5mg per day) | Drug | antiviral group |
| radical resection of HBV-related HCCProcedure/Surgery - radical resection of HBV-related HCC | Procedure or surgery | antiviral group, control group |
Primary outcome
Overall survivals
Time frame: 2,3,5years
1 secondary outcome
Recurrence rate
Time frame: 2,3,5years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2009.
- Background: PubMed 16440357Jang 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.
- Background: PubMed 17724708Jang 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.
- Background: PubMed 15336446Jang 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.
- Background: PubMed 17881079Poon 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.
- Background: PubMed 17854945Sun 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.
- Background: PubMed 12098045Kubo 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.
- Background: PubMed 11141236Kubo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Qing LI, Ph.D principal investigator
Sun Yat-sen University
Min-Shan CHEN, Ph.D study director
Sun Yat-sen University
Xiao-Jun LIN, Ph.D study director
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing antiviral treatment (lamivudine or entecavir) and radical resection of HBV-related HCC in people with Hepatocellular Carcinoma and Hepatitis B Virus, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang-Ming LAO, Ph.D (8620-87343115, laoxming@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survivals (time frame: 2,3,5years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00768157, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2009.