Recurrent Hepatocellular CarcinomaHCCTACEAFPNCT02728219
Comparison of Treatment of Recurrent HCC With Repeat Hepatectomy,and TACE With AFP Conversion
A study testing TACE and Hepatectomy in people with Recurrent Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
The purpose of this study is to compare the treatment of recurrent hepatocellular carcinoma with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP conversion. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Recurrent Hepatocellular Carcinoma
- What is being tested?
- TACE and Hepatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- May 2012to May 2015
- 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
- via clinical diagnosis and confirm it is early recurrent liver cancer with AFP conversion, and not accept any anticancer treatment.
- age:18-70years
- better liver function (Child-Pugh，class A or B)
Who cannot join
- reject to attend；
- impossible to come to our hospital for physical examination regularly.
- cancer epitome、seed focus、lymph node or distant metastasis
- Blood clotting function hindrance;
- serious heart、lung、kidney disease
Trial locations and contacts
1 site in 1 country.
China1 site
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438
About this study
Official title: A Prospective Randomized Trial Comparing Treatment of Recurrent HCC With Repeat Hepatectomy,and Transcatheter Arterial Chemoembolization (TACE) With AFP Conversion
The purpose of this study is to compare the treatment of recurrent hepatocellular carcinoma with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP conversion.
Read the detailed description
Though many HCC patients have been benefited from hepatectomy treatment, still the high recurrence rate after the hepatectomy led to limited effectiveness.
This is the first study in same case system on comparison of effectiveness among repeat hepatectomy, and TACE with AFP conversion.
- Conditions
- Recurrent Hepatocellular Carcinoma
- Being tested
- TACE, Hepatectomy
- Keywords
- Recurrent Hepatocellular Carcinoma, transcatheter arterial chemoembolization, AFP conversion
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
Also called transcatheter arterial chemoembolization
In this study we prospectively select some early diagnosed recurrent HCC patients after radical resection with AFP conversion, then they will be treated with transcatheter arterial chemoembolization (TACE)
HepatectomyProcedure or surgery
Repeat Hepatectomy after postoperation recurrence
| Study group | Role | What they receive |
|---|---|---|
| hepatectomy | Experimental | Comparison of Treatment of recurrent hepatocellular carcinoma with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP conversion Receives: Procedure: TACE |
| TACE | Active comparator | Not described Receives: Procedure: Hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startMay 2012
- Primary completionNov 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Hepatocellular CarcinomaStudies 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
- 150 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728219
- Sponsor's protocol ID
- 2012ZX10002016007002
- Acronym
- HCCTACEAFP
- Status last verified
- Mar 2016
- First submitted
- 28 Mar 2016
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Treatment of Recurrent HCC With Repeat Hepatectomy,and Transcatheter Arterial Chemoembolization (TACE) With AFP Conversion
- ClinicalTrials.gov ID
- NCT02728219
- Acronym / sponsor ID
- HCCTACEAFP / 2012ZX10002016007002
- Conditions
- Recurrent Hepatocellular Carcinoma
- Keywords
- Recurrent Hepatocellular Carcinoma, transcatheter arterial chemoembolization, AFP conversion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 5 Apr 2016 (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 compare the treatment of recurrent hepatocellular carcinoma with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP conversion.
Detailed description
Though many HCC patients have been benefited from hepatectomy treatment, still the high recurrence rate after the hepatectomy led to limited effectiveness.
This is the first study in same case system on comparison of effectiveness among repeat hepatectomy, and TACE with AFP conversion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hepatectomy | Experimental | Procedure: TACEComparison of Treatment of recurrent hepatocellular carcinoma with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP conversion |
| TACE | Active comparator | Procedure: Hepatectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- via clinical diagnosis and confirm it is early recurrent liver cancer with AFP conversion, and not accept any anticancer treatment.
- age:18-70years
- better liver function (Child-Pugh，class A or B)
Key exclusion criteria (5 listed)
- reject to attend；
- impossible to come to our hospital for physical examination regularly.
- cancer epitome、seed focus、lymph node or distant metastasis
- Blood clotting function hindrance;
- serious heart、lung、kidney disease
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 |
|---|---|---|
| TACEAlso: transcatheter arterial chemoembolizationIn this study we prospectively select some early diagnosed recurrent HCC patients after radical resection with AFP conversion, then they will be treated with transcatheter arterial chemoembolization (TACE) | Procedure or surgery | hepatectomy |
| HepatectomyRepeat Hepatectomy after postoperation recurrence | Procedure or surgery | TACE |
Primary outcome
overall survival
Time frame: 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 5 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TACE and Hepatectomy in people with Recurrent Hepatocellular Carcinoma, 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 3 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 5 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?
overall survival (time frame: 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 5 Apr 2016.