HCCREPEATNCT01470495
Combined Treatment of RFA and Sorafenib on Recurrent HCC
A study testing RFA + Sorafenib and RFA in people with HCC and Radiofrequency Ablation, run by Southwest Hospital, China at 1 site in China.
Trial summary
RFA is a routaine treatment of recurrent HCC. Recently Sorafenib was reported to be a promising drug to treat late stage HCC. But few studies were related with its effectiveness on recurrent HCC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC, Radiofrequency Ablation, Sorafenib
- What is being tested?
- RFA + Sorafenib and RFA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 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
- recurrent HCC after curative resection
- without gender restriction
- age between 18 to 75 years
- The liver function showed no worse than Child-Pugh B
- tumor nodes were less than 5cm and no more than 3 nodules
Who cannot join
- Pregnancy patients
- With extrahepatic tumor or lymphnode metastasis
- Tumor invasion or thrombosis in portal vein,hepatic vein or inferior vena cava
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of hepatobiliary surgery,southwest hospital
Chongqing, Chongqing Municipality, 400038
feng xiaobin, MD, +86-23-13228683243, fengxiaobin200708@yahoo.com.cn
feng xiaobin, MD
About this study
Official title: Radiofrequency Ablation Plus Sorafenib Administration in Early Recurrent Hepatocellular Carcinoma: a Prospective Multicenter Cohort Trial (Repeat) Tumors for BCLC B Stage HCC Undergone Curative Hepatectomy
RFA is a routaine treatment of recurrent HCC. Recently Sorafenib was reported to be a promising drug to treat late stage HCC. But few studies were related with its effectiveness on recurrent HCC. So the investigators hypothesized that combined RFA and Sorafenib might reduce the frequency of recurrence and improve the overall survival and disease free survial.
- Conditions
- HCC, Radiofrequency Ablation, Sorafenib
- Being tested
- RFA + Sorafenib, RFA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFA + SorafenibOther
combined RFA and Sorafenib to treat recurrent HCC
RFAOther
treat Recurrent HCC with RFA
| Study group | Role | What they receive |
|---|---|---|
| RFA+Sorafenib | Experimental | to treat recurrent HCC both with RFA and Sorafenib Receives: Other: RFA + Sorafenib |
| RFA group | Active comparator | To treat recurrent HCC with RFA Receives: Other: RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
time interval between new lessions emerging after the first HCC recurrence
Measured: 3 year
Secondary outcomes (1)
3-year overrall survival
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startJan 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Province Tumor Hospital, Tang-Du Hospital, Xijing Hospital, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital Xi'an Jiaotong University, Anhui Provincial Hospital, Xiangya Hospital of Central South University, Xinqiao Hospital of Chongqing, Xinjiang Tumor Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, Henan Cancer Hospital, People's Hospital of Sichuan, Huaxi Hospital
- Responsible party
- Principal investigator, feng xiaobin, Southwest Hospital, China
- Investigators
- Kuansheng Ma, MD,Ph.D, Principal investigator, Southwest Hopstial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470495
- Sponsor's protocol ID
- swhb005
- Acronym
- REPEAT
- Status last verified
- Mar 2017
- First submitted
- 9 Nov 2011
- 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
- Radiofrequency Ablation Plus Sorafenib Administration in Early Recurrent Hepatocellular Carcinoma: a Prospective Multicenter Cohort Trial (Repeat) Tumors for BCLC B Stage HCC Undergone Curative Hepatectomy
- ClinicalTrials.gov ID
- NCT01470495
- Acronym / sponsor ID
- REPEAT / swhb005
- Conditions
- HCC, Radiofrequency Ablation, Sorafenib
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Collaborators
- Hunan Province Tumor Hospital, Tang-Du Hospital, Xijing Hospital, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital Xi'an Jiaotong University, Anhui Provincial Hospital, Xiangya Hospital of Central South University, Xinqiao Hospital of Chongqing, Xinjiang Tumor Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, Henan Cancer Hospital, People's Hospital of Sichuan, Huaxi Hospital
- Study start
- Jan 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 11 Nov 2011 (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.
RFA is a routaine treatment of recurrent HCC. Recently Sorafenib was reported to be a promising drug to treat late stage HCC. But few studies were related with its effectiveness on recurrent HCC. So the investigators hypothesized that combined RFA and Sorafenib might reduce the frequency of recurrence and improve the overall survival and disease free survial.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA+Sorafenib | Experimental | Other: RFA + Sorafenibto treat recurrent HCC both with RFA and Sorafenib |
| RFA group | Active comparator | Other: RFATo treat recurrent HCC with RFA |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- recurrent HCC after curative resection
- without gender restriction
- age between 18 to 75 years
- The liver function showed no worse than Child-Pugh B
- tumor nodes were less than 5cm and no more than 3 nodules
Key exclusion criteria (3 listed)
- Pregnancy patients
- With extrahepatic tumor or lymphnode metastasis
- Tumor invasion or thrombosis in portal vein,hepatic vein or inferior vena cava
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 + Sorafenibcombined RFA and Sorafenib to treat recurrent HCC | Other | RFA+Sorafenib |
| RFAtreat Recurrent HCC with RFA | Other | RFA group |
Primary outcome
time interval between new lessions emerging after the first HCC recurrence
Time frame: 3 year
1 secondary outcome
3-year overrall survival
Time frame: 3 year
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.
Kuansheng Ma, MD,Ph.D principal investigator
Southwest Hopstial
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 + Sorafenib and RFA in people with HCC and Radiofrequency Ablation, 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 5 inclusion and 3 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 Xiaobin Feng, MD (+86-2368765297, fengxiaobin200708@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time interval between new lessions emerging after the first HCC recurrence (time frame: 3 year). 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.