Hepatocellular CarcinomaPhase 3TACE+RFANCT03636620
TACE Combined With RFA/MV Treatment in Hepatocellular Carcinoma Beyond Milan Criterial
A Phase 3 study testing Transcatheter arterial chemoembolization and radiofrequency ablation/microwave ablation in people with Hepatocellular Carcinoma, run by Fudan University at 1 site in China.
Trial summary
This study was designed to evaluate the effectiveness of radiofrequency /microwave ablation in patients with hepatocellular carcinoma beyond Milan Criteria. 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 and radiofrequency ablation/microwave ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Aug 2018
- Phase
- Phase 3
- 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 diganosed with hepatocellualr carcinoma beyond Milan criteria
- the presence of a single HCC tumor ≤7 cm in diameter, or multi-nodular HCC tumors (n ≤ 5) small than 7 cm in diameter;
- Child-Pugh A or B
- ECOG score 0-1;
- prothrombin time ≤16 s;
- white cell count ≥3,000/mm3, platelet count ≥40 x 109/L;Hb≥8.5 g/d; ALT/AST≤5×ULN;TB≤3mg/dl;alb≥2.8 g/dl ;Scr ≤2mg/dl
Who cannot join
- expected survival time < 12 months before random assignment;
- received anticancer surgery or procedure within one month before assignment;
- concomitant use of any other anticancer therapy(except immunotherapy and herbal medicine ) ;
- existence of portal of hepatic vein invation or extrahepatic metastases;existence of active infection ;
- upper gastrointestinal hemorrhage within one month ; .other serious illness or medical condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of Transcatheter Arterial Chemoembolization Combined With Radiofrequency/Microwave Ablation in Hepatocellular Carcinoma Beyond Milan Criterial
This study was designed to evaluate the effectiveness of radiofrequency /microwave ablation in patients with hepatocellular carcinoma beyond Milan Criteria.
Read the detailed description
The aim of this study is to included 120 patients with intermediate stage hepatocellular carcinoma beyond Milan criteria .These patients were randomizedly allocated to TACE treatment group or TACE+RFA/MV .The treatment effectiveness, local tumor control and survival outcome between the two groups were compared.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Transcatheter arterial chemoembolization, radiofrequency ablation/microwave ablation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter arterial chemoembolizationDevice
Also called TACE
Transcatheter arterial chemoembolization
radiofrequency ablation/microwave ablationDevice
Also called RFA/MW
radiofrequency ablation/microwave ablation
| Study group | Role | What they receive |
|---|---|---|
| TACE group | Active comparator | Transcatheter arterial chemoembolization Receives: Device: Transcatheter arterial chemoembolization |
| TACE+RFA/MV group | Experimental | Transcatheter arterial chemoembolization and radiofrequency /microwave ablation Receives: Device: Transcatheter arterial chemoembolization; Device: radiofrequency ablation/microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: up to 46 months
Secondary outcomes (1)
objective response rate
Measured: up to 46 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study startJun 2013
- Primary completionAug 2018
- Study completionAug 2018
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- TACE vs.TACE+RFA
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng-Gang Ren, Fudan University
- Investigators
- zheng-gang Ren, doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636620
- Sponsor's protocol ID
- LC-TACE+RFA/MV
- Acronym
- TACE+RFA
- Status last verified
- Aug 2018
- First submitted
- 8 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: no plan to make individual paticipant data available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Transcatheter Arterial Chemoembolization Combined With Radiofrequency/Microwave Ablation in Hepatocellular Carcinoma Beyond Milan Criterial
- ClinicalTrials.gov ID
- NCT03636620
- Acronym / sponsor ID
- TACE+RFA / LC-TACE+RFA/MV
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 17 Aug 2018 (actual)
- 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.
This study was designed to evaluate the effectiveness of radiofrequency /microwave ablation in patients with hepatocellular carcinoma beyond Milan Criteria.
Detailed description
The aim of this study is to included 120 patients with intermediate stage hepatocellular carcinoma beyond Milan criteria .These patients were randomizedly allocated to TACE treatment group or TACE+RFA/MV .The treatment effectiveness, local tumor control and survival outcome between the two groups were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- TACE vs.TACE+RFA
| Arm | Type | Receives |
|---|---|---|
| TACE group | Active comparator | Device: Transcatheter arterial chemoembolizationTranscatheter arterial chemoembolization |
| TACE+RFA/MV group | Experimental | Device: Transcatheter arterial chemoembolization, Device: radiofrequency ablation/microwave ablationTranscatheter arterial chemoembolization and radiofrequency /microwave ablation |
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 diganosed with hepatocellualr carcinoma beyond Milan criteria
- the presence of a single HCC tumor ≤7 cm in diameter, or multi-nodular HCC tumors (n ≤ 5) small than 7 cm in diameter;
- Child-Pugh A or B
- ECOG score 0-1;
- prothrombin time ≤16 s;
Key exclusion criteria (5 listed)
- expected survival time < 12 months before random assignment;
- received anticancer surgery or procedure within one month before assignment;
- concomitant use of any other anticancer therapy(except immunotherapy and herbal medicine ) ;
- existence of portal of hepatic vein invation or extrahepatic metastases;existence of active infection ;
- upper gastrointestinal hemorrhage within one month ; .other serious illness or medical condition.
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 chemoembolizationAlso: TACETranscatheter arterial chemoembolization | Device | TACE group, TACE+RFA/MV group |
| radiofrequency ablation/microwave ablationAlso: RFA/MWradiofrequency ablation/microwave ablation | Device | TACE+RFA/MV group |
Primary outcome
overall survival
Time frame: up to 46 months
1 secondary outcome
objective response rate
Time frame: up to 46 months
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 17 Aug 2018.
- Individual participant dataSharing planned: No. no plan to make individual paticipant data available to other researchers
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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.
zheng-gang Ren, doctor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transcatheter arterial chemoembolization and radiofrequency ablation/microwave ablation 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 6 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 17 Aug 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (time frame: up to 46 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 17 Aug 2018.