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

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the effects of Transcatheter Arterial Chemoembolization (TACE) with KMG microsphere in treating advance-stage Hepatocellular Carinoma(HCC).

Detailed Description
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This is a prospective, multicentre, random, controlled clinical trial of Transcatheter Arterial Chemoembolization (TACE)with KMG Microsphere Treating Advance-stage Hepatocellular Carinomas.

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

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Procedure: 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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Accepts Healthy Volunteers

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 | Procedure: 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） | Procedure: 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） | Procedure: Therapeutic Chemoembolization<br>* Transcatheter Arterial Chemoembolization<br>* Other names: Transcatheter Arterial Chemoembolization，TACE;|
| Experimental: TACE-KMG(withou chemo)<br>embolization agent:KMG microsphere( 150-450µm,0.2-2g) | Procedure: 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 year | 
| remission rate | remiision rate | 3 years | 

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