TACE Combined With RFA/MV Treatment in Hepatocellular Carcinoma Beyond Milan Criterial

Study Overview
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Brief Summary
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This study was designed to evaluate the effectiveness of radiofrequency /microwave ablation in patients with hepatocellular carcinoma beyond Milan Criteria.

Detailed Description
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The aim of this study is to included 120 patients with intermediate stage hepatocellular carcinoma beyond Milan criteria .These patients were randomizedly allocated to TACE treatment group or TACE+RFA/MV .The treatment effectiveness, local tumor control and survival outcome between the two groups were compared.

Official Title
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Clinical Trial of Transcatheter Arterial Chemoembolization Combined With Radiofrequency/Microwave Ablation in Hepatocellular Carcinoma Beyond Milan Criterial

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Device: Transcatheter arterial chemoembolization
* Device: radiofrequency ablation/microwave ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients diganosed with hepatocellualr carcinoma beyond Milan criteria the presence of a single HCC tumor ≤7 cm in diameter, or multi-nodular HCC tumors (n ≤ 5) small than 7 cm in diameter; Child-Pugh A or B ECOG score 0-1; prothrombin time ≤16 s; white cell count ≥3,000/mm3, platelet count ≥40 x 109/L;Hb≥8.5 g/d; ALT/AST≤5×ULN;TB≤3mg/dl;alb≥2.8 g/dl ;Scr ≤2mg/dl Exclusion Criteria: expected survival time < 12 months before random assignment; received anticancer surgery or procedure within one month before assignment; concomitant use of any other anticancer therapy(except immunotherapy and herbal medicine ) ; existence of portal of hepatic vein invation or extrahepatic metastases;existence of active infection ; upper gastrointestinal hemorrhage within one month ; .other serious illness or medical condition.

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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: TACE vs.TACE+RFA
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TACE group<br>Transcatheter arterial chemoembolization | Device: Transcatheter arterial chemoembolization<br>* Transcatheter arterial chemoembolization<br>* Other names: TACE;|
| Experimental: TACE+RFA/MV group<br>Transcatheter arterial chemoembolization and radiofrequency /microwave ablation | Device: Transcatheter arterial chemoembolization<br>* Transcatheter arterial chemoembolization<br>* Other names: TACE;Device: radiofrequency ablation/microwave ablation<br>* radiofrequency ablation/microwave ablation<br>* Other names: RFA/MW;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | up to 46 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate |  | up to 46 months |