Liver CancerPhase 2NCT02202564
Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma
A Phase 2 study testing LT, ADV-TK and ganciclovir in people with Liver Cancer and Hepatocellular Carcinoma, run by Huazhong University of Science and Technology.
Trial summary
HCC patients with tumors >5 cm in diameter, regardless of involvement in the intrahepatic and extrahepatic portal branches participated in the study. Patients were randomized allocated in liver transplantation (LT) only group and LT plus ADV-TK therapy group. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cancer, Hepatocellular Carcinoma
- What is being tested?
- LT, ADV-TK and ganciclovir
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Aug 2013
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18～70 years of age (Male and Female).
- Clinical diagnosis of advanced hepatocellular carcinoma who could accept liver transplantation
- Patients who had unresectable HCC >5 cm and no metastasis in lungs and bones were eligible to participate in this study. Tumor involvement in the intrahepatic and extrahepatic portal branches was not considered to be an exclusion criterion.
- No prior chemotherapy, radiation therapy, targeted therapy or other kind of biological treatment within 4 weeks.
- Provide written informed consent
Who cannot join
- Metastasis in lungs and bones
- Invasion in main vescular.
- Contraindications of liver transplantation
- Contraindications of operation of other organ system
- Hypersensitivity to adenovirus, GCV or similar drugs
- Accept clinical trials of other drugs
Show all 9Show fewer
- Immunological deficit
- Active pregnancy
- Unable or unwilling to sign informed consents
About this study
HCC patients with tumors >5 cm in diameter, regardless of involvement in the intrahepatic and extrahepatic portal branches participated in the study. Patients were randomized allocated in liver transplantation (LT) only group and LT plus ADV-TK therapy group. All patients received orthotopic liver transplantation; in the LT plus ADV-TK group, ADV-TK therapy was delivered to patients twice.
- Conditions
- Liver Cancer, Hepatocellular Carcinoma
- Being tested
- LT, ADV-TK, ganciclovir
- Keywords
- hepatocellular carcinoma, liver transplantation, adenovirus-thymidine kinase, gene therapy
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTProcedure or surgery
Also called liver transplantation
Orthotopic LT
ADV-TKDrug
Also called adenovirus-thymidine kinase
ganciclovirDrug
| Study group | Role | What they receive |
|---|---|---|
| LT+ADV-TK | Experimental | Liver transplantation and double-dose ADV-TK/ganciclovir administration The first ADV-TK dose was administered before closing the peritoneal layer; the second ADV-TK dose was administered 2 months after LT; ganciclovir was slowly administered 36 hours after LT and twice daily for 14 days. Receives: Procedure: LT; Drug: ADV-TK; Drug: ganciclovir |
| LT | Active comparator | Orthotopic liver transplantation Receives: Procedure: LT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Measured: up to 3-year
Recurrence-free survival rate
Measured: up to 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startOct 2006
- Primary completionOct 2011
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing YouAn Hospital
- Responsible party
- Principal investigator, Ding Ma, Huazhong University of Science and Technology
- Investigators
- Ding Ma, M.D., Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202564
- Sponsor's protocol ID
- LT-02
- Status last verified
- Jul 2014
- First submitted
- 26 Jul 2014
- Last updated
- 29 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02202564
- Acronym / sponsor ID
- LT-02
- Conditions
- Liver Cancer, Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, liver transplantation, adenovirus-thymidine kinase, gene therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Beijing YouAn Hospital
- Study start
- Oct 2006
- Primary completion
- Oct 2011 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 29 Jul 2014 (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.
HCC patients with tumors >5 cm in diameter, regardless of involvement in the intrahepatic and extrahepatic portal branches participated in the study. Patients were randomized allocated in liver transplantation (LT) only group and LT plus ADV-TK therapy group. All patients received orthotopic liver transplantation; in the LT plus ADV-TK group, ADV-TK therapy was delivered to patients twice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LT+ADV-TK | Experimental | Procedure: LT, Drug: ADV-TK, Drug: ganciclovirLiver transplantation and double-dose ADV-TK/ganciclovir administration The first ADV-TK dose was administered before closing the peritoneal layer; the second ADV-TK dose was administered 2 months after LT; ganciclovir was slowly administered 36 hours after LT and twice daily for 14 days. |
| LT | Active comparator | Procedure: LTOrthotopic liver transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18～70 years of age (Male and Female).
- Clinical diagnosis of advanced hepatocellular carcinoma who could accept liver transplantation
- Patients who had unresectable HCC >5 cm and no metastasis in lungs and bones were eligible to participate in this study. Tumor involvement in the intrahepatic and extrahepatic portal branches was not considered to be an exclusion criterion.
- No prior chemotherapy, radiation therapy, targeted therapy or other kind of biological treatment within 4 weeks.
- Provide written informed consent
Key exclusion criteria (9 listed)
- Metastasis in lungs and bones
- Invasion in main vescular.
- Contraindications of liver transplantation
- Contraindications of operation of other organ system
- Hypersensitivity to adenovirus, GCV or similar drugs
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 |
|---|---|---|
| LTAlso: liver transplantationOrthotopic LT | Procedure or surgery | LT, LT+ADV-TK |
| ADV-TKAlso: adenovirus-thymidine kinase | Drug | LT+ADV-TK |
| ganciclovir | Drug | LT+ADV-TK |
Primary outcome
Overall survival rate
Time frame: up to 3-year
Recurrence-free survival rate
Time frame: up to 3-year
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 29 Jul 2014.
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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. principal investigator
Huazhong University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LT, ADV-TK and ganciclovir in people with Liver Cancer and Hepatocellular Carcinoma, run by Huazhong University of Science and Technology.
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 5 inclusion and 9 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 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: up to 3-year). The study lists 2 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 29 Jul 2014.