Transcatheter Arterial Chemoembolization With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas (TACE-KMG)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of Transcatheter Arterial Chemoembolization (TACE) with KMG microsphere in treating HCC. And to determine which one is better,KMG microsphere or lipiodol?

Detailed Description
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The most important part of effect in TACE is embolization .But there is no clinical trials on which one is better,KMG microsphere or lipiodol? what effect did chemo play in the TACE treating HCC? Which one is better,routine dose or low dose? Experts in USA and Japan had their own researches and standpoints.We think it is important to push a clinical trail to answer these problem.

Official Title
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Clinical Trial of Transcatheter Arterial Chemoembolization (TACE)With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Other: Therapeutic Chemoembolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hepatocellular Carinomas with diagnosis of pathology or cytology or consistent with China 2001 guideline of Clinical Diagnosis Hepatocellular Carinomas clinical stage（The Barcelona Liver Clinic staging system,BCLC B and C)，or can not receive surgical intervention liver function:Child-Pugh A、B PST 0-1（Eastern Cooperative Oncology Group Performance Score ,ECOG） Lifespan≥6 months First time to receive treatment Can accept the follow up informed consent was gotten the number of lesion ≤ 5 Exclusion Criteria: pregnant or lactation woman emotional disturbance serious heart ,lung disfunction or serious diabetes mellitus serious reactiveness infections;（exp:type B or C hepatitis） liver function :Child-Pugh Score C thrombocyte<6×109/L diffuse HCC widespread metastasis serious atherosclerosis acquired immunodeficiency syndrome;AIDS thrombosis or thrombosis event in 6 months renal inadequacy who need hemodialysis or peritoneal dialysis with other tumors except basal cell carcinoma and carcinoma in situ of cervix serious alimentary tract hemorrhage in 4 weeks

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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TACE -oil<br>embolization agent:Iodinated Oil or /and gelatin sponge Iodinated Oil （5-30ml）with Epirubicin （30-40mg/m2） or and gelatin sponge | Other: Therapeutic Chemoembolization<br>* Transcatheter Arterial Chemoembolization<br>* Other names: Transcatheter Arterial Chemoembolization，TACE;|
| Experimental: TACE-KMG ( routine dose Chemo)<br>embolization agent:KMG microsphere( 150-450µm,0.2-2g) with routine dose Epirubicin （30-40mg/m2） | Other: Therapeutic Chemoembolization<br>* Transcatheter Arterial Chemoembolization<br>* Other names: Transcatheter Arterial Chemoembolization，TACE;|
| Experimental: TACE-KMG( low dose Chemo )<br>embolization agent:KMG microsphere( 150-450µm,0.2-2g) with low dose Epirubicin （5-10mg/m2） | Other: Therapeutic Chemoembolization<br>* Transcatheter Arterial Chemoembolization<br>* Other names: Transcatheter Arterial Chemoembolization，TACE;|
| Experimental: TACE-KMG(without chemo)<br>embolization agent:KMG microsphere( 150-450µm,0.2-2g) | Other: Therapeutic Chemoembolization<br>* Transcatheter Arterial Chemoembolization<br>* Other names: Transcatheter Arterial Chemoembolization，TACE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression | Time to progression | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total survival | total survival | 3 years | 
| remission rate | remission rate | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC, TACE