Primary Liver CancerNCT00824707
Efficacy and Significance of Antiviral Therapy for Unresectable Hepatitis B Virus-related Primary Liver Cancer
A study testing Entecavir and conventional therapy in people with Primary Liver Cancer, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
This study is working to research the efficacy and significant of the anti-virus therapy in the unresectable Hepatitis B virus (HBV) related primary liver cancer(PLC) so as to establish treatment standards of anti-virus therapy in PLC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Liver Cancer
- What is being tested?
- Entecavir and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Dec 2008to Dec 2010
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identify patients with PLC in accordance with the clinical diagnostic criteria of PLC.Patients with PLC shall be diagnosed with or without pathology. It is not appropriate to perform liver resection operation.
- serum positive HBsAg≥6 months.
- Criteria of liver function: Child A or B level, serum total bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 10 times the upper limit of normal value.
- hemoglobin≥8.5g/dl, PT-INR≤2.3 or PT>6 seconds of normal value.
- No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
- Patients who can understand this trial, male or female, aged 18-70 voluntarily participate in clinical trials and have signed information consent.
Who cannot join
- Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction, which may affect the treatment of liver cancer.
- Patients with other diseases which may affect the treatment mentioned here.
- Patients with medical history of other malignant tumors.
- Subjects participating in other clinical trials.
- Women in pregnancy and breast-feeding.
Trial locations and contacts
1 site in 1 country.
China1 site
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, 200438
About this study
Official title: A Randomized, Controlled Study to Evaluate the Efficacy and Significant of the Anti-virus Therapy for the Unresectable Hepatitis B Virus-related Primary Liver Cancer
This study is working to research the efficacy and significant of the anti-virus therapy in the unresectable Hepatitis B virus (HBV) related primary liver cancer(PLC) so as to establish treatment standards of anti-virus therapy in PLC.
Read the detailed description
primary liver cancer(PLC)is one of the world's most common malignancies, especially in East-Asian countries.Hepatitis B virus (HBV) infection is associated with 70-90% of PLC cases in China. PLC can develop during any stage of the natural course of chronic HBV infection and anti-virus therapy should be considered during the management of PLC. However, there is no definite guide on when or how to practice the anti-virus therapy, especially in unresectable or inoperable PLC. Because of these facts, research on the significant of the anti-virus therapy in the HBV-related PLC is urgently needed.
200 patients will be randomly assigned to anti-virus therapy group and control gruop.The time to progression(TTP) and overall survival within two years will be used to evaluate the effect of anti-virus therapy on PLC.
The aim of this study is to research the efficacy and significant of the anti-virus therapy in the unresectable HBV-related PLC so as to establish treatment standards of anti-virus therapy in PLC.
- Conditions
- Primary Liver Cancer
- Being tested
- Entecavir, conventional therapy
- Keywords
- primary liver cancer, hepatitis B virus, anti-virus therapy
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecavirDrug
Also called anti-virus group
Entecavir 0.5mg per day
Also called control group
conventional therapy including protecting the liver function, anti-tumor and so on
| Study group | Role | What they receive |
|---|---|---|
| anti-virus therapy | Experimental | 100 HCC patients will be allocated to receive anti-virus therapy. Receives: Drug: Entecavir |
| conventional therapy | Active comparator | 100 patients will undergo conventional therapy Receives: Drug: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
time-to-progression(TTP)
Measured: 1,2 and 3 years
Secondary outcomes (2)
Overall survival (OS)
Measured: 1,2 and 3 years
The overall response rate
Measured: 1,2 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Liver CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShenFeng, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Shen Feng, M.D, Study chair, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824707
- Sponsor's protocol ID
- EHBH-RCT-2008-005
- Status last verified
- Mar 2016
- First submitted
- 16 Jan 2009
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study to Evaluate the Efficacy and Significant of the Anti-virus Therapy for the Unresectable Hepatitis B Virus-related Primary Liver Cancer
- ClinicalTrials.gov ID
- NCT00824707
- Acronym / sponsor ID
- EHBH-RCT-2008-005
- Conditions
- Primary Liver Cancer
- Keywords
- primary liver cancer, hepatitis B virus, anti-virus therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Jan 2009 (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.
This study is working to research the efficacy and significant of the anti-virus therapy in the unresectable Hepatitis B virus (HBV) related primary liver cancer(PLC) so as to establish treatment standards of anti-virus therapy in PLC.
Detailed description
primary liver cancer(PLC)is one of the world's most common malignancies, especially in East-Asian countries.Hepatitis B virus (HBV) infection is associated with 70-90% of PLC cases in China. PLC can develop during any stage of the natural course of chronic HBV infection and anti-virus therapy should be considered during the management of PLC. However, there is no definite guide on when or how to practice the anti-virus therapy, especially in unresectable or inoperable PLC. Because of these facts, research on the significant of the anti-virus therapy in the HBV-related PLC is urgently needed.
200 patients will be randomly assigned to anti-virus therapy group and control gruop.The time to progression(TTP) and overall survival within two years will be used to evaluate the effect of anti-virus therapy on PLC.
The aim of this study is to research the efficacy and significant of the anti-virus therapy in the unresectable HBV-related PLC so as to establish treatment standards of anti-virus therapy in PLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anti-virus therapy | Experimental | Drug: Entecavir100 HCC patients will be allocated to receive anti-virus therapy. |
| conventional therapy | Active comparator | Drug: conventional therapy100 patients will undergo conventional therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Identify patients with PLC in accordance with the clinical diagnostic criteria of PLC.Patients with PLC shall be diagnosed with or without pathology. It is not appropriate to perform liver resection operation.
- serum positive HBsAg≥6 months.
- Criteria of liver function: Child A or B level, serum total bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 10 times the upper limit of normal value.
- hemoglobin≥8.5g/dl, PT-INR≤2.3 or PT>6 seconds of normal value.
- No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
Key exclusion criteria (5 listed)
- Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction, which may affect the treatment of liver cancer.
- Patients with other diseases which may affect the treatment mentioned here.
- Patients with medical history of other malignant tumors.
- Subjects participating in other clinical trials.
- Women in pregnancy and breast-feeding.
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 |
|---|---|---|
| EntecavirAlso: anti-virus groupEntecavir 0.5mg per day | Drug | anti-virus therapy |
| conventional therapyAlso: control groupconventional therapy including protecting the liver function, anti-tumor and so on | Drug | conventional therapy |
Primary outcome
time-to-progression(TTP)
Time frame: 1,2 and 3 years
2 secondary outcomes
Overall survival (OS)
Time frame: 1,2 and 3 years
The overall response rate
Time frame: 1,2 and 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
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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.
Shen Feng, M.D study chair
Eastern Hepatobiliary Surgery Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entecavir and conventional therapy in people with Primary Liver Cancer, run by Eastern Hepatobiliary Surgery Hospital 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 1 Apr 2016. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time-to-progression(TTP) (time frame: 1,2 and 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2016.