Transarterial Chemoembolization for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

Phase 4

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: transcatheter arterial chemoembolization

• Registration Number: NCT00646100
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-27
• Study First Posted: 2008-03-28
• Primary Completion: 2009-07
• Study Completion: 2010-02
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TACE	transcatheter arterial chemoembolization	chemo-lipiodolization with EADM 50mg, Lobaplatin 50mg, and MMC 6mg,plus particleembolization

Primary Outcome Measures

Name	Time	Method
survival rates	6, 12 months

Secondary Outcome Measures

Name	Time	Method
quality of life	6, 12 months

Trial Locations

Locations (1)

Cancer Canter Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China