Radiofrequency Ablation Accompanied With Spontaneous Sorafenib in Early to Intermediate Stage HCC
NCT ID: NCT02187081
Last Updated: 2017-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
380 participants
INTERVENTIONAL
2017-03-15
2018-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sorafenib+RFA
We give radiofrequency ablation plus Sorafenib for the treatment of HCC
radiofrequency ablation plus Sorafenib
To treat HCC with the combination of radiofrequency ablation and sorafenib
RFA alone
We give Radiofrequency ablation alone for the treatment of HCC
Radiofrequency ablation
To treat HCC with radiofrequency ablation alone.
Interventions
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radiofrequency ablation plus Sorafenib
To treat HCC with the combination of radiofrequency ablation and sorafenib
Radiofrequency ablation
To treat HCC with radiofrequency ablation alone.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* Any treatment history of target lesion including chemotherapy and TACE
* Pregnancy
* received other trials on gene therapy
* have received operation less than 4 weeks
18 Years
70 Years
ALL
No
Sponsors
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Southwest Hospital, China
OTHER
Responsible Party
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feng xiaobin
Dr Xiaobin Feng
Locations
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Southwest Hospital
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xiaobin Feng
Role: primary
Other Identifiers
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SWHB008
Identifier Type: -
Identifier Source: org_study_id
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