Hepatocellular CarcinomaPhase 2NCT00300521
Liver Transplantation With ADV-TK Gene Therapy Improves Survival in Patients With Advanced Hepatocellular Carcinoma
A Phase 2 study testing ADV-TK (adenovirus-thymidine kinase enzyme) gene therapy in people with Hepatocellular Carcinoma and Liver Transplantation, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
Previous rather poor results in liver transplantation (LT) of patients with advanced hepatocellular carcinoma (HCC) have made the application of LT very limited in treatment of HCC. The advantages of ADV-TK gene therapy highlight its potentiality as adjuvant treatment for HCC patients after LT. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Transplantation
- What is being tested?
- ADV-TK (adenovirus-thymidine kinase enzyme) gene therapy
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Sep 2000to Nov 2005
- Phase
- Phase 2
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of advanced hepatocellular carcinoma with no metastasis in lungs and bones
- Accept Liver Transplantation
Who cannot join
- Small hepatocellular carcinoma
- Advanced hepatocellular with metastasis in lungs and bones
Trial locations and contacts
1 site in 1 country.
About this study
Previous rather poor results in liver transplantation (LT) of patients with advanced hepatocellular carcinoma (HCC) have made the application of LT very limited in treatment of HCC. The advantages of ADV-TK gene therapy highlight its potentiality as adjuvant treatment for HCC patients after LT. We reported here the improved outcome of LT with combined treatment of ADV-TK gene therapy in patients with intermediate or advanced HCC.
Read the detailed description
The overall survival in the LT with ADV-TK gene therapy group was 54.8 % at three years, and the recurrence-free survival in the same group was 56.5 %, both being higher than those in the transplantation only group (P=0.0001 for overall survival and P=0.0000 for recurrence-free survival). In no-vascular invasion subgroup treated with LT with ADV-TK therapy, both overall survival and recurrence-free survival were 100 %, significantly higher than those with vascular invasion subgroup treated with the combined LT and ADV-TK therapy (P=0 for each group). Vascular invasion was an important factor affected survival and recurrence, hazard ratio=3.687; P=0.014 and hazard ratio=12.961; P=0.000, respectively.
- Conditions
- Hepatocellular Carcinoma, Liver Transplantation
- Being tested
- ADV-TK (adenovirus-thymidine kinase enzyme) gene therapy
- Keywords
- hepatocellular carcinoma, liver transplantation, adenovirus-thymidine kinase enzyme, gene therapy, immunosuppression
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADV-TK (adenovirus-thymidine kinase enzyme) gene therapyGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival rate at one year
overall survival rate at two year
overall survival rate at three year
overall recurrence-free survival rate at one year
overall recurrence-free survival rate at two year
overall recurrence-free survival rate at three year
Secondary outcomes (5)
AFP level before and after liver transplantation
hazard rate of age on survival rate and recurrence-free survival rate
hazard rate of TNM stage on survival rate and recurrence-free survival rate
hazard rate of Child-Pugh classification on survival rate and recurrence-free survival rate
hazard rate of vascular invasion on survival rate and recurrence-free survival rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2006 (estimated)
- Study startSep 2000
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji University, The No.180 Hospital of People's Liberation Army
- Investigators
- Ding Ma, M.D., Study chair, Cancer Biology Research Center, Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology, Wuhan, Hubei 430030, P.R.ChinaNing Li, B.D, Study director, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300521
- Sponsor's protocol ID
- LT2000-09
- Status last verified
- Sep 2000
- First submitted
- 8 Mar 2006
- Last updated
- 9 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Transplantation With ADV-TK Gene Therapy Improves Survival in Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00300521
- Acronym / sponsor ID
- LT2000-09
- Conditions
- Hepatocellular Carcinoma, Liver Transplantation
- Keywords
- hepatocellular carcinoma, liver transplantation, adenovirus-thymidine kinase enzyme, gene therapy, immunosuppression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- Tongji University, The No.180 Hospital of People's Liberation Army
- Study start
- Sep 2000
- Study completion
- Nov 2005
- First posted
- 9 Mar 2006 (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.
Previous rather poor results in liver transplantation (LT) of patients with advanced hepatocellular carcinoma (HCC) have made the application of LT very limited in treatment of HCC. The advantages of ADV-TK gene therapy highlight its potentiality as adjuvant treatment for HCC patients after LT. We reported here the improved outcome of LT with combined treatment of ADV-TK gene therapy in patients with intermediate or advanced HCC.
Detailed description
The overall survival in the LT with ADV-TK gene therapy group was 54.8 % at three years, and the recurrence-free survival in the same group was 56.5 %, both being higher than those in the transplantation only group (P=0.0001 for overall survival and P=0.0000 for recurrence-free survival). In no-vascular invasion subgroup treated with LT with ADV-TK therapy, both overall survival and recurrence-free survival were 100 %, significantly higher than those with vascular invasion subgroup treated with the combined LT and ADV-TK therapy (P=0 for each group). Vascular invasion was an important factor affected survival and recurrence, hazard ratio=3.687; P=0.014 and hazard ratio=12.961; P=0.000, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of advanced hepatocellular carcinoma with no metastasis in lungs and bones
- Accept Liver Transplantation
Key exclusion criteria (2 listed)
- Small hepatocellular carcinoma
- Advanced hepatocellular with metastasis in lungs and bones
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 |
|---|---|---|
| ADV-TK (adenovirus-thymidine kinase enzyme) gene therapy | Genetic | – |
Primary outcome
overall survival rate at one year
overall survival rate at two year
overall survival rate at three year
overall recurrence-free survival rate at one year
overall recurrence-free survival rate at two year
overall recurrence-free survival rate at three year
5 secondary outcomes
AFP level before and after liver transplantation
hazard rate of age on survival rate and recurrence-free survival rate
hazard rate of TNM stage on survival rate and recurrence-free survival rate
hazard rate of Child-Pugh classification on survival rate and recurrence-free survival rate
hazard rate of vascular invasion on survival rate and recurrence-free survival rate
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 9 Mar 2006.
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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.
Ding Ma, M.D. study chair
Cancer Biology Research Center, Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology, Wuhan, Hubei 430030, P.R.China
Ning Li, B.D study director
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADV-TK (adenovirus-thymidine kinase enzyme) gene therapy in people with Hepatocellular Carcinoma and Liver Transplantation, run by Beijing Chao Yang 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 2 inclusion and 2 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 9 Mar 2006. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
overall survival rate at one year. The study lists 6 primary outcomes in all. 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 9 Mar 2006.