Efficacy and Safety of Sorafenib as Adjuvant and Latter Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma

Study Overview
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Brief Summary
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Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study.

Detailed Description
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Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study. Eligible cases will be assigned into the experimental group and the control group. For experiment group, sorafenib tablet will be given for two weeks, and then perform radiofrequency ablation. For the control group, RFA will be performed immediately.

Official Title
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Efficacy and Safety of Combination of Sorafenib as Preoperative Adjuvant and Latter Radiofrequency Ablation in the Treatment Of Recurrent Hepatocellular Carcinoma: A Prospective Multicenter Cohort Study

Conditions
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HCC

Intervention / Treatment
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* Procedure: RFA
* Drug: Sorafenib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged from 18 to 75 years old Without gender restriction With a favorable liver function of Child-Pugh A to B No contraindications to RFA and anesthesia Diagnosed with Recurrent HCC Signed informed consent. Exclusion Criteria: Cancer thrombosis in major vessels/ extrahepatic metastasis Uncontrollable ascites or variceal bleeding Impairment in liver function Severe disorders in vital organ Accompanied with other tumors or infectious disease except hepatitis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sorafenib+RFA group<br>for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation | Procedure: RFA<br>* for eligible cases, radiofrequency ablation will be given only.<br>* Other names: control group;Drug: Sorafenib<br>* for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation<br>* Other names: experimental group;|
| Active Comparator: RFA group<br>for eligible cases, RFA will be given only. | Procedure: RFA<br>* for eligible cases, radiofrequency ablation will be given only.<br>* Other names: control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | 1 year Disease free survival | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time To Recurrence | time to tumor recurrence | 3 year | 
| Overall Survival | overall survival | 3 year | 
| postoperative complications | postoperative complications diagnosed within 6 months | 6 months | 
| Health economics index | Health economics index within 3 years | 3 years | 
| mortality | mortality occured within 3 months | 3 months |