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

Sun Yat-sen University1 site in 1 country164 target enrollmentJuly 2007

ConditionsHepatocellular Carcinoma

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Hepatocellular Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 164
Locations: 1
Primary Endpoint: survival rates
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2007

End Date

February 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Shi Ming

Professor

Sun Yat-sen University

Eligibility Criteria

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