Hepatocellular CarcinomaNCT02728193
Standard Treatments of Very-early Stage Hepatocellular Carcinoma
A study testing RFA, MWV and PEI in people with Hepatocellular Carcinoma and Very-early Stage, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
The aim of our study was to elucidate the difference in the rates of complication, hospitalization days, medical expenses, MRI showed that the degree of tumor necrosis, and overall survival rates of the therapies between PEI, MVA and RFA, and make the standard for minimally invasive treatment of very early stage HCC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma, Very-early Stage
- What is being tested?
- RFA, MWV and PEI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Dec 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
- Preoperative clinical, imaging and tumor markers were diagnosed as hepatocellular carcinoma
- Tumor diameter<2cm
- Child-Pugh class A liver function
- Without major organ dysfunction
- male or female patients > 18 years and <=70 years of age
- Voluntary participation in this clinical trial
Who cannot join
- Other anticancer treatment before therapy
- Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer
- Patients with other diseases that may affect the treatment of this treatment
- History of other malignant tumors
- Patients who are participating in other clinical trials
- Pregnant, lactating women
Trial locations and contacts
1 site in 1 country.
China1 site
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438
About this study
Official title: The Research on Standard Treatments of Very-early Stage Hepatocellular Carcinoma: a Randomized Clinical Trial
The aim of our study was to elucidate the difference in the rates of complication, hospitalization days, medical expenses, MRI showed that the degree of tumor necrosis, and overall survival rates of the therapies between PEI, MVA and RFA, and make the standard for minimally invasive treatment of very early stage HCC.
- Conditions
- Hepatocellular Carcinoma, Very-early Stage
- Being tested
- RFA, MWV, PEI
- Keywords
- treatments, hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFAProcedure or surgery
MWVProcedure or surgery
Also called Microwave ablation
PEIProcedure or surgery
Percutaneous ethanol injection
| Study group | Role | What they receive |
|---|---|---|
| RFA | Experimental | Radiofrequency ablation Receives: Procedure: RFA |
| MWV | Experimental | Microwave ablation Receives: Procedure: MWV |
| PEI | Experimental | Percutaneous ethanol injection Receives: Procedure: PEI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Hepatocellular Carcinoma will recurrence in 3 years
Measured: 3 years
Death
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 startDec 2012
- Primary completionDec 2014
- Study completionDec 2015
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.
- 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
- 300 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
- NCT02728193
- Sponsor's protocol ID
- 2012ZX10002016003001
- 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
- The Research on Standard Treatments of Very-early Stage Hepatocellular Carcinoma: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02728193
- Acronym / sponsor ID
- 2012ZX10002016003001
- Conditions
- Hepatocellular Carcinoma, Very-early Stage
- Keywords
- treatments, hepatocellular carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 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 aim of our study was to elucidate the difference in the rates of complication, hospitalization days, medical expenses, MRI showed that the degree of tumor necrosis, and overall survival rates of the therapies between PEI, MVA and RFA, and make the standard for minimally invasive treatment of very early stage HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RFA | Experimental | Procedure: RFARadiofrequency ablation |
| MWV | Experimental | Procedure: MWVMicrowave ablation |
| PEI | Experimental | Procedure: PEIPercutaneous ethanol injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Preoperative clinical, imaging and tumor markers were diagnosed as hepatocellular carcinoma
- Tumor diameter<2cm
- Child-Pugh class A liver function
- Without major organ dysfunction
- male or female patients > 18 years and <=70 years of age
Key exclusion criteria (6 listed)
- Other anticancer treatment before therapy
- Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer
- Patients with other diseases that may affect the treatment of this treatment
- History of other malignant tumors
- Patients who are participating in other clinical trials
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 |
|---|---|---|
| RFA | Procedure or surgery | RFA |
| MWVAlso: Microwave ablation | Procedure or surgery | MWV |
| PEIPercutaneous ethanol injection | Procedure or surgery | PEI |
Primary outcome
Recurrence
Time frame: 3 years
Hepatocellular Carcinoma will recurrence in 3 years
Death
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 RFA, MWV and PEI in people with Hepatocellular Carcinoma and Very-early Stage, 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 6 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?
Recurrence (time frame: 3 years). 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 5 Apr 2016.