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Completed

NCT Number: NCT00646100

Transarterial Chemoembolization for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cancer Canter Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcatheter arterial chemoembolization

Procedure

chemo-lipiodolization with EADM 50mg, Lobaplatin 50mg, and MMC 6mg,plus particleembolization.

Other names: TACE

Primary outcomes

  1. survival rates

    Time frame: 6, 12 months

Secondary outcomes

  1. quality of life

    Time frame: 6, 12 months

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Acronym: TACEHCC

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Mar 28, 2008
Registry last updated
Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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