HCCNCT02187081
Radiofrequency Ablation Accompanied With Spontaneous Sorafenib in Early to Intermediate Stage HCC
A study testing radiofrequency ablation plus Sorafenib and Radiofrequency ablation in people with HCC, run by Southwest Hospital, China at 1 site in China.
Trial summary
Radiofrequency ablation (RFA)can be curative with small localized HCCs up to 5 cm in diameter. However, the long-term prognosis is not satisfactory due to the high incidence of recurrence.Multimodality treatments are needed to prevent recurrences，but only useful with locoregional disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HCC
- What is being tested?
- radiofrequency ablation plus Sorafenib and Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2017to 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Authorization of Informed Consent
- HCC diagnosed by biopsy or Image findings
- BCLC stage 0 to B1
- This time was the primary treatment of HCC. Had no history of any tumor specific therapy,including RFA,Hepatectomy,TACE,HIFU,and Transplantation
- Child Pugh A or B
- ECOG 0 to 2
Show all 15Show fewer
- single lesion less than or equal to 5 cm,2 to 3 nodules, maximal size less than equal to 3cm
- Male or female (without pregnancy)
- Ages between 18 to 70 years
- Capable of take medicines
- anticipate at least survival of 12 weeks
- Unwilling to receive surgical resection or liver transplantation
- Potentially curable disease by RFA
- Sorafenib administrated less than 4 weeks before or after RFA procedures
- For any excuse,subject should take Sorafenib at least for 4 weeks
Who cannot join
- A cancer embolus in major hepatic vessels or extrahepatic metastases
- Tumor number more than 4 or tumor size larger than 5 cm
- A present or past history of uncontrollable ascites, hepatic encephalopathy or variceal bleeding
- A history of a secondary malignancy
- Severe dysfunction of the heart, kidney or other organs
- Active infection except viral hepatitis
Show all 10Show fewer
- Any treatment history of target lesion including chemotherapy and TACE
- Pregnancy
- received other trials on gene therapy
- have received operation less than 4 weeks
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Xiaobin Feng
Kuansheng Ma, Ph.D
About this study
Official title: Radiofrequency Ablation Accompanied With Spontaneous Sorafenib Administration in the Treatment of Early to Intermediate Stage Hepatocellular Carcinoma: a Prospective Multicenter Cohort Study.(REASSESS)
Radiofrequency ablation (RFA)can be curative with small localized HCCs up to 5 cm in diameter. However, the long-term prognosis is not satisfactory due to the high incidence of recurrence.Multimodality treatments are needed to prevent recurrences，but only useful with locoregional disease. Sorafenib is an oral multi-kinase inhibitor and the only systemic drug associated with improved overall survival (OS) in patients with advanced HCC. Retrospective and randomized studies have suggested that the combined use of Sorafenib may be useful in patients with unresectable HCC. Based on these information and the multiple actions of Sorafenib, we hypothesized that Sorafenib plus RFA may be useful in patients with early to Mid term HCC. In this investigation, we evaluated the safety and efficacy of a combination Sorafenib and RFA therapy in patients with Barcelona Clinic Liver Cancer (BCLC) Stage 0 -B1 HCC in a multicenter prospective cohort study.
Read the detailed description
Radiofrequency ablation (RFA) has been used as a minimally invasive option to eradicate tumors and preserve liver function in patients with impaired function or with a postoperative tumor recurrence. RFA can be curative with small localized HCCs up to 5 cm in diameter. However, the long-term prognosis for HCC patients treated with RFA is not satisfactory due to the high incidence of recurrence including local tumor recurrence and multicentric carcinogenesis.
Multimodality treatments are needed to prevent recurrences. Although there is a potential benefit with this strategy, it is only useful with locoregional disease. Sorafenib is an oral multi-kinase inhibitor and the only systemic drug associated with improved overall survival (OS) in patients with advanced HCC.
Retrospective and randomized studies have suggested that the combined use of Sorafenib, TACE, and RFA may be useful in patients with unresectable HCC. Based on these information and the multiple actions of Sorafenib, we hypothesized that Sorafenib plus RFA may be useful in patients with early HCC or recurrent HCC. Although no supportive data from clinical trials is available, this hypothesis is supported by recent animal studies. Inadequate RFA has been shown to promote rapid progression of residual tumors. Adjuvant Sorafenib postponed time to recurrence by inhibition of hypoxia inducible factor-1and vascular endothelial growth factor A (VEGFA). In a multifocal tumor model of HCC, RFA and Sorafenib alone resulted in a significant volume reduction of non-RFA-targeted tumors, but this effect was enhanced when both modalities were combined. This phenomenon was also demonstrated by more recent study on human subject.
Besides the advantages, Sorafenib initially promoted necrosis, delayed tissue repair after RFA and adversely affected normal liver parenchyma, which could result in increased RFA toxicity and limit its use in patients with HCC who have undergone RFA. Thus, the overall advantages of RFA plus Sorafenib need to be weighed against its adverse effects. In this investigation, we evaluated the safety and efficacy of a combination Sorafenib and RFA therapy in patients with Barcelona Clinic Liver Cancer (BCLC) Stage 0 -B1 HCC in a multicenter prospective cohort study.
Outcome measures: Post-RFA tumor recurrence
- Conditions
- HCC
- Being tested
- radiofrequency ablation plus Sorafenib, Radiofrequency ablation
- Keywords
- HCC, RFA, Sorafenib, Tumor recurrence, Overall survival
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablation plus SorafenibProcedure or surgery
To treat HCC with the combination of radiofrequency ablation and sorafenib
Radiofrequency ablationProcedure or surgery
To treat HCC with radiofrequency ablation alone.
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib+RFA | Experimental | We give radiofrequency ablation plus Sorafenib for the treatment of HCC Receives: Procedure: radiofrequency ablation plus Sorafenib |
| RFA alone | Active comparator | We give Radiofrequency ablation alone for the treatment of HCC Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year incidence of tumor recurrence
to calculate the incidence of tumor recurrence of experiment and control group at two year after complete treatment.
Measured: 2 year
Secondary outcomes (7)
Overall survival
Overall survival
Measured: 5 years
1-year incidence of recurrence
1-year incidence of recurrence
Measured: 1-year
3-year incidence of recurrence
3-year incidence of recurrence
Measured: 3 year
5-year incidence of recurrence
5-year incidence of recurrence
Measured: 5 year
Time to progression
Time to progression
Measured: average 2 years
Disease Control Rate
Disease Control Rate
Measured: average 2 years
complications and adverse effect
to sum all the complications and adverse effect for all the eligible enrolled patients during 1 year of a complete treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study start15 Mar 2017
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, feng xiaobin, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187081
- Sponsor's protocol ID
- SWHB008
- Status last verified
- Mar 2017
- First submitted
- 1 Jul 2014
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Accompanied With Spontaneous Sorafenib Administration in the Treatment of Early to Intermediate Stage Hepatocellular Carcinoma: a Prospective Multicenter Cohort Study.(REASSESS)
- ClinicalTrials.gov ID
- NCT02187081
- Acronym / sponsor ID
- SWHB008
- Conditions
- HCC
- Keywords
- HCC, RFA, Sorafenib, Tumor recurrence, Overall survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 10 Jul 2014 (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.
Radiofrequency ablation (RFA)can be curative with small localized HCCs up to 5 cm in diameter. However, the long-term prognosis is not satisfactory due to the high incidence of recurrence.Multimodality treatments are needed to prevent recurrences，but only useful with locoregional disease. Sorafenib is an oral multi-kinase inhibitor and the only systemic drug associated with improved overall survival (OS) in patients with advanced HCC. Retrospective and randomized studies have suggested that the combined use of Sorafenib may be useful in patients with unresectable HCC. Based on these information and the multiple actions of Sorafenib, we hypothesized that Sorafenib plus RFA may be useful in patients with early to Mid term HCC. In this investigation, we evaluated the safety and efficacy of a combination Sorafenib and RFA therapy in patients with Barcelona Clinic Liver Cancer (BCLC) Stage 0 -B1 HCC in a multicenter prospective cohort study.
Detailed description
Radiofrequency ablation (RFA) has been used as a minimally invasive option to eradicate tumors and preserve liver function in patients with impaired function or with a postoperative tumor recurrence. RFA can be curative with small localized HCCs up to 5 cm in diameter. However, the long-term prognosis for HCC patients treated with RFA is not satisfactory due to the high incidence of recurrence including local tumor recurrence and multicentric carcinogenesis.
Multimodality treatments are needed to prevent recurrences. Although there is a potential benefit with this strategy, it is only useful with locoregional disease. Sorafenib is an oral multi-kinase inhibitor and the only systemic drug associated with improved overall survival (OS) in patients with advanced HCC.
Retrospective and randomized studies have suggested that the combined use of Sorafenib, TACE, and RFA may be useful in patients with unresectable HCC. Based on these information and the multiple actions of Sorafenib, we hypothesized that Sorafenib plus RFA may be useful in patients with early HCC or recurrent HCC. Although no supportive data from clinical trials is available, this hypothesis is supported by recent animal studies. Inadequate RFA has been shown to promote rapid progression of residual tumors. Adjuvant Sorafenib postponed time to recurrence by inhibition of hypoxia inducible factor-1and vascular endothelial growth factor A (VEGFA). In a multifocal tumor model of HCC, RFA and Sorafenib alone resulted in a significant volume reduction of non-RFA-targeted tumors, but this effect was enhanced when both modalities were combined. This phenomenon was also demonstrated by more recent study on human subject.
Besides the advantages, Sorafenib initially promoted necrosis, delayed tissue repair after RFA and adversely affected normal liver parenchyma, which could result in increased RFA toxicity and limit its use in patients with HCC who have undergone RFA. Thus, the overall advantages of RFA plus Sorafenib need to be weighed against its adverse effects. In this investigation, we evaluated the safety and efficacy of a combination Sorafenib and RFA therapy in patients with Barcelona Clinic Liver Cancer (BCLC) Stage 0 -B1 HCC in a multicenter prospective cohort study.
Outcome measures: Post-RFA tumor recurrence
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sorafenib+RFA | Experimental | Procedure: radiofrequency ablation plus SorafenibWe give radiofrequency ablation plus Sorafenib for the treatment of HCC |
| RFA alone | Active comparator | Procedure: Radiofrequency ablationWe give Radiofrequency ablation alone for the treatment of HCC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Authorization of Informed Consent
- HCC diagnosed by biopsy or Image findings
- BCLC stage 0 to B1
- This time was the primary treatment of HCC. Had no history of any tumor specific therapy,including RFA,Hepatectomy,TACE,HIFU,and Transplantation
- Child Pugh A or B
Key exclusion criteria (10 listed)
- A cancer embolus in major hepatic vessels or extrahepatic metastases
- Tumor number more than 4 or tumor size larger than 5 cm
- A present or past history of uncontrollable ascites, hepatic encephalopathy or variceal bleeding
- A history of a secondary malignancy
- Severe dysfunction of the heart, kidney or other organs
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 plus SorafenibTo treat HCC with the combination of radiofrequency ablation and sorafenib | Procedure or surgery | Sorafenib+RFA |
| Radiofrequency ablationTo treat HCC with radiofrequency ablation alone. | Procedure or surgery | RFA alone |
Primary outcome
2-year incidence of tumor recurrence
Time frame: 2 year
to calculate the incidence of tumor recurrence of experiment and control group at two year after complete treatment.
7 secondary outcomes
Overall survival
Time frame: 5 years
1-year incidence of recurrence
Time frame: 1-year
3-year incidence of recurrence
Time frame: 3 year
5-year incidence of recurrence
Time frame: 5 year
Time to progression
Time frame: average 2 years
Disease Control Rate
Time frame: average 2 years
complications and adverse effect
Time frame: 1 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.
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 plus Sorafenib and Radiofrequency ablation in people with HCC, 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 15 inclusion and 10 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, Docter (86-23-68765297, fengxiaobin200708@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year incidence of tumor recurrence (time frame: 2 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.