Cancer of LiverNCT00730860
Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation (RFA) Associated With Postoperative TACE
A study testing radiofrequency ablation associated with TACE and radiofrequency ablation only in people with Cancer of Liver, run by Southwest Hospital, China at 1 site in China.
Trial summary
A RCT was conducted to elucidate whether the treatment outcome of HCC could be improved by RFA associated with postoperative TACE. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer of Liver
- What is being tested?
- radiofrequency ablation associated with TACE and radiofrequency ablation only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Jun 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with hepatocellular,confirmed by pathological examination
- patients with a live function test showed Child A or B
- Indocyanine green test showed less than 30％ after 15min,and the patients showed a tolerance of RFA and TACE
- Tumor stage is early period(according to Milan Standard),that is,the diameter of single node should be less than 5cm；the node of tumor should be less than 3 and the diameter less than 3cm.
- without metastasis in lymphnode or other organs
- written consent inform assigned
Who cannot join
- preoperative examination showed malignant thrombosis in the first class branch of portal vein or hepatic vein or vena cava
- metastatic cancer of liver
- patients with a poor tolerance of RFA and TACE
- patients received other therapies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of hepatobiliary surgery
Chongqing, Chongqing Municipality, 400038
Ma Kuansheng, Ph.D, 86-23-68765297, xiaobinf@medmail.com.cn
Feng Xiaobin, M.D
About this study
Official title: Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation Associated With Postoperative Transhepatic Arterial Chemoembolization--a Prospective Randomized Clinical Trial
A RCT was conducted to elucidate whether the treatment outcome of HCC could be improved by RFA associated with postoperative TACE.
Read the detailed description
A randomized study was conducted to elucidate whether the outcome of hepatocellular carcinoma could be improved by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization.
- Conditions
- Cancer of Liver
- Being tested
- radiofrequency ablation associated with TACE, radiofrequency ablation only
- Keywords
- radiofrequency ablation, Cancer of Liver, postoperative, transhepatic arterial chemoembolization, prospective
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablation associated with TACEProcedure or surgery
Also called Group A
treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization
radiofrequency ablation onlyProcedure or surgery
Also called Group B
treatment of hepatocellular carcinoma by radiofrequency ablation only
| Study group | Role | What they receive |
|---|---|---|
| RFA+TACE | Experimental | treatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization Receives: Procedure: radiofrequency ablation associated with TACE |
| RFA only | Active comparator | treatment of hepatocellular carcinoma by radiofrequency ablation only Receives: Procedure: radiofrequency ablation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Measured: 3 years
Secondary outcomes (1)
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 posted8 Aug 2008 (estimated)
- Study startDec 2009
- Primary completion30 Jan 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of LiverStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Science, Technology and Research
- Responsible party
- Principal investigator, feng xiaobin, Southwest Hospital, China
- Investigators
- Ma Kuansheng, Ph.D, Study director, Institute of hepatobiliary surgery,Southwest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730860
- Sponsor's protocol ID
- SWHB002
- Status last verified
- Mar 2017
- First submitted
- 6 Aug 2008
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hepatocellular Carcinoma With Radiofrequency Ablation Associated With Postoperative Transhepatic Arterial Chemoembolization--a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00730860
- Acronym / sponsor ID
- SWHB002
- Conditions
- Cancer of Liver
- Keywords
- radiofrequency ablation, Cancer of Liver, postoperative, transhepatic arterial chemoembolization, prospective
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Collaborators
- Agency for Science, Technology and Research
- Study start
- Dec 2009 (actual)
- Primary completion
- 30 Jan 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 8 Aug 2008 (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.
A RCT was conducted to elucidate whether the treatment outcome of HCC could be improved by RFA associated with postoperative TACE.
Detailed description
A randomized study was conducted to elucidate whether the outcome of hepatocellular carcinoma could be improved by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA+TACE | Experimental | Procedure: radiofrequency ablation associated with TACEtreatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization |
| RFA only | Active comparator | Procedure: radiofrequency ablation onlytreatment of hepatocellular carcinoma by radiofrequency ablation only |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients with hepatocellular,confirmed by pathological examination
- patients with a live function test showed Child A or B
- Indocyanine green test showed less than 30％ after 15min,and the patients showed a tolerance of RFA and TACE
- Tumor stage is early period(according to Milan Standard),that is,the diameter of single node should be less than 5cm；the node of tumor should be less than 3 and the diameter less than 3cm.
- without metastasis in lymphnode or other organs
Key exclusion criteria (4 listed)
- preoperative examination showed malignant thrombosis in the first class branch of portal vein or hepatic vein or vena cava
- metastatic cancer of liver
- patients with a poor tolerance of RFA and TACE
- patients received other therapies.
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 |
|---|---|---|
| radiofrequency ablation associated with TACEAlso: Group Atreatment of hepatocellular carcinoma by radiofrequency ablation associated with postoperative transhepatic arterial chemoembolization | Procedure or surgery | RFA+TACE |
| radiofrequency ablation onlyAlso: Group Btreatment of hepatocellular carcinoma by radiofrequency ablation only | Procedure or surgery | RFA only |
Primary outcome
disease free survival
Time frame: 3 years
1 secondary outcome
overall survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
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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.
Ma Kuansheng, Ph.D study director
Institute of hepatobiliary surgery,Southwest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency ablation associated with TACE and radiofrequency ablation only in people with Cancer of Liver, run by Southwest Hospital, China 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 4 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 28 Mar 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Xiaobin, M.D (+86-23-68765297, fengxiaobin200708@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free 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 28 Mar 2017.