Hepatocellular CarcinomaPhase 2/3NCT03642561
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
A Phase 2/3 study testing radiotherapy ablation and transarterial chemoembolization(TACE) in people with Hepatocellular Carcinoma, run by Fudan University at 1 site in China.
Trial summary
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE 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?
- radiotherapy ablation and transarterial chemoembolization(TACE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2019to 1 Aug 2022
- Phase
- Phase 2/3
- 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
- age 18 to 75 years ;
- HCC confirmed by pathological or clinical diagnosis according to the American Association for the Study of Liver Diseases criteria ;
- solitary HCC less than 7cm in diameter or multiple HCC lesions less 5
- the absence of portal/hepatic vein invasion, lymph node involvement and extrahepatic metastases;
- lesions visible on ultrasound with a safe path between the lesion and skin;
- an Eastern Cooperative Oncology Group performance status of 0-1;
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- Child-Pugh class A or B cirrhosis.
- The exclusion criteria :
- received any other previous treatment for HCC;
- severe coagulation disorders;
- evidence of hepatic decompensation including hepatic encephalopathy, ascites as well as esophageal or gastric variceal bleeding;
- presence of serious medical comorbidities, including serious dysfunction of the heart or kidney ;
- currently had other malignancies in addition to HCC.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan hospital Fudan University
Shanghai
Xin Yin, doctor, yin.xin@zs-hospital.sh.cn
zhenggang Ren, professor
About this study
Official title: Liver Cancer Institiute ,Fudan University
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
Read the detailed description
The investigators conduct this clinical trial to evaluate the treatment outcome of RFA in HCC patients with tumor smaller than 7cm and tumor number less than five ,in comparison with TACE treatment.The primary outcome is overall survival.The secondary outcome is objective response rate.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- radiotherapy ablation, transarterial chemoembolization(TACE)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapy ablationDevice
We using Cool Tip system or RITA system to perform RFA
transarterial chemoembolization(TACE)Device
TACE treatment is a first line treatment for BCLC stage B HCC
| Study group | Role | What they receive |
|---|---|---|
| RFA group | Experimental | Patients in RFA group will accept RFA treatment Receives: Device: radiotherapy ablation |
| TACE group | Active comparator | Patients in TACE group will accept TACE treatment Receives: Device: transarterial chemoembolization(TACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: up to 60 months
Secondary outcomes (1)
objective response rate
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start3 Sep 2019
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group 1 RFA alone group 2 TACE alone
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng-Gang Ren, Fudan University
- Investigators
- Zhenggang Ren, doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642561
- Sponsor's protocol ID
- LC-RFA vs.TACE
- Status last verified
- Jul 2020
- First submitted
- 8 Aug 2018
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make IPDavailable to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Cancer Institiute ,Fudan University
- ClinicalTrials.gov ID
- NCT03642561
- Acronym / sponsor ID
- LC-RFA vs.TACE
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 22 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.
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
Detailed description
The investigators conduct this clinical trial to evaluate the treatment outcome of RFA in HCC patients with tumor smaller than 7cm and tumor number less than five ,in comparison with TACE treatment.The primary outcome is overall survival.The secondary outcome is objective response rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- group 1 RFA alone group 2 TACE alone
| Arm | Type | Receives |
|---|---|---|
| RFA group | Experimental | Device: radiotherapy ablationPatients in RFA group will accept RFA treatment |
| TACE group | Active comparator | Device: transarterial chemoembolization(TACE)Patients in TACE group will accept TACE treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- age 18 to 75 years ;
- HCC confirmed by pathological or clinical diagnosis according to the American Association for the Study of Liver Diseases criteria ;
- solitary HCC less than 7cm in diameter or multiple HCC lesions less 5
- the absence of portal/hepatic vein invasion, lymph node involvement and extrahepatic metastases;
- lesions visible on ultrasound with a safe path between the lesion and skin;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| radiotherapy ablationWe using Cool Tip system or RITA system to perform RFA | Device | RFA group |
| transarterial chemoembolization(TACE)TACE treatment is a first line treatment for BCLC stage B HCC | Device | TACE group |
Primary outcome
overall survival
Time frame: up to 60 months
1 secondary outcome
objective response rate
Time frame: up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No. No plan to make IPDavailable 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.
Zhenggang 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 2/3 study testing radiotherapy ablation and transarterial chemoembolization(TACE) 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 13 inclusion and 0 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 Jul 2020. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Yin, doctor (+86-21-64041990, yin.xin@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: up to 60 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 28 Jul 2020; AzTrials last refreshed its copy on 6 Nov 2026.