Hepatocellular CarcinomaPhase 4TACEHBVNCT01102335
Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy
A Phase 4 study testing Transcatheter arterial chemoembolization (TACE) and Telbivudine in people with Hepatocellular Carcinoma, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to elucidate the influence of anti-hepatitis B virus therapy on safety and survival of HCC patient after transcatheter arterial chemoembolization. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Transcatheter arterial chemoembolization (TACE) and Telbivudine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to Dec 2012
- 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
- hepatocellular carcinoma
- treated with transcatheter arterial chemoembolization (TACE)
- HBVDNA > 10^3copies/mL, including alanine aminotransferase (ALT) normal patient
- expected survive time > 1 year
- HBV marker positive (anyone of HbsAg, HbsAb, HbeAg, HbeAb and HbcAb)
Who cannot join
- antiviral therapy history
- alanine aminotransferase (ALT) >400 U/L
- serum total bilirubin > 50 μmol/L
- HBVDNA > 10^9copies/mL
- extrahepatic metastasis or main portal vein embolus
- apparent cardiac or pulmonary dysfunction
- liver function: Child B or Child C
- HCV infection
Trial locations and contacts
1 site in 1 country.
jinglin xia, MD contact
biwei yang contact
China1 site, 1 recruiting
- Recruiting
Liver cancer institute, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
jinglin xia, MD
jinglin xia, MD
About this study
Official title: The Observation Of Safety And Survival Of Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization Combined With Anti-hepatitis B Virus Therapy
The purpose of this study is to elucidate the influence of anti-hepatitis B virus therapy on safety and survival of HCC patient after transcatheter arterial chemoembolization.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Transcatheter arterial chemoembolization (TACE), Telbivudine
- Keywords
- hepatitis B virus, Antiviral Agents, Liver Neoplasms, Drug Toxicity, Survival
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis B, Liver Neoplasms, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter arterial chemoembolization (TACE)Procedure or surgery
The procedure is performed under local anaesthesia. The femoral artery at groin region is punctured for arterial access. Angiography is performed for demonstration of vascular structures before embolization.The arteries supplying the tumor are selectively catheterized, this includes the hepatic arteries or other extrahepatic collateral arteries.The chemotherapeutic agent(s) is mixed with lipiodol (an oily contrast) to enhance tumour uptake. Following delivery of the lipiodol/chemotherapy mixture, small gelfoam particles may be injected to reinforce the effect of treatment.
TelbivudineDrug
Also called Sebivo
anti-HBV drug
| Study group | Role | What they receive |
|---|---|---|
| Telbivudine | Experimental | Not described Receives: Procedure: Transcatheter arterial chemoembolization (TACE); Drug: Telbivudine |
| TACE only | Active comparator | Not described Receives: Procedure: Transcatheter arterial chemoembolization (TACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 6 months
Secondary outcomes (1)
Overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2012 (estimated)
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 Fudan 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- jinglin xia, MD, Principal investigator, Liver cancer institute, Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102335
- Sponsor's protocol ID
- LCI-001
- Acronym
- TACEHBV
- Status last verified
- Apr 2010
- First submitted
- 8 Apr 2010
- Last updated
- 13 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Observation Of Safety And Survival Of Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization Combined With Anti-hepatitis B Virus Therapy
- ClinicalTrials.gov ID
- NCT01102335
- Acronym / sponsor ID
- TACEHBV / LCI-001
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatitis B virus, Antiviral Agents, Liver Neoplasms, Drug Toxicity, Survival
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 13 Apr 2010 (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.
The purpose of this study is to elucidate the influence of anti-hepatitis B virus therapy on safety and survival of HCC patient after transcatheter arterial chemoembolization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telbivudine | Experimental | Procedure: Transcatheter arterial chemoembolization (TACE), Drug: Telbivudine |
| TACE only | Active comparator | Procedure: Transcatheter arterial chemoembolization (TACE) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- hepatocellular carcinoma
- treated with transcatheter arterial chemoembolization (TACE)
- HBVDNA > 10^3copies/mL, including alanine aminotransferase (ALT) normal patient
- expected survive time > 1 year
- HBV marker positive (anyone of HbsAg, HbsAb, HbeAg, HbeAb and HbcAb)
Key exclusion criteria (8 listed)
- antiviral therapy history
- alanine aminotransferase (ALT) >400 U/L
- serum total bilirubin > 50 μmol/L
- HBVDNA > 10^9copies/mL
- extrahepatic metastasis or main portal vein embolus
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 |
|---|---|---|
| Transcatheter arterial chemoembolization (TACE)The procedure is performed under local anaesthesia. The femoral artery at groin region is punctured for arterial access. Angiography is performed for demonstration of vascular structures before embolization.The arteries supplying the tumor are selectively catheterized, this includes the hepatic arteries or other extrahepatic collateral arteries.The chemotherapeutic agent(s) is mixed with lipiodol (an oily contrast) to enhance tumour uptake. Following delivery of the lipiodol/chemotherapy mixture, small gelfoam particles may be injected to reinforce the effect of treatment. | Procedure or surgery | TACE only, Telbivudine |
| TelbivudineAlso: Sebivoanti-HBV drug | Drug | Telbivudine |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 6 months
1 secondary outcome
Overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2010.
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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.
jinglin xia, MD contact
biwei yang contact
jinglin xia, MD principal investigator
Liver cancer institute, Zhongshan Hospital
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 Transcatheter arterial chemoembolization (TACE) and Telbivudine in people with Hepatocellular Carcinoma, run by Fudan 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 5 inclusion and 8 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 13 Apr 2010. 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 jinglin xia, MD (xia.jinglin@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 6 months). 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 13 Apr 2010.