Transarterial Chemoembolization for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

Study Overview
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Brief Summary
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Transcatheter arterial chemoembolization (TACE) had been proved to improve the survivals for middle stage hepatocellular carcinoma (HCC), but for advanced stage HCC its' efficacy had not been proved. The investigators hypothesize that TACE also improve the survivals for advanced stage HCC. Thus, the investigators carried out this prospective control study to find out if the survivals for patients after TACE better than only best support or not.

Official Title
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Transarterial Chemoembolization Versus Best Support for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: transcatheter arterial chemoembolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) Tumor size >7 cm with a portal vein invasion, and the tumor was considered to be unresectable No previous HCC directed treatment Eastern Co-operative Group performance status 0-1 Liver function: Child's A Exclusion Criteria: Avascular tumor Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy underlying serve cardiac or renal diseases Known or suspected allergy to the investigational agent or any agent given in association with this trial Diffuse-type HCC For patients with main portal vein occlusion, no adequate collateral circulation around the occluded portal vein

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 |
| --- | --- |
| Active Comparator: TACE<br>chemo-lipiodolization with EADM 50mg, Lobaplatin 50mg, and MMC 6mg,plus particleembolization | Procedure: transcatheter arterial chemoembolization<br>* chemo-lipiodolization with EADM 50mg, Lobaplatin 50mg, and MMC 6mg,plus particleembolization.<br>* Other names: TACE;|
| No Intervention: control<br>best support care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rates |  | 6, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | 6, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, transcatheter arterial chemoembolization, prospective control study, best support care, survival