Transarterial Chemoembolization for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

NCT00646100 | Completed Phase 4 DMC

• 1 other identifier: TACE1
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; transcatheter arterial chemoembolization; prospective control study; best support care; survival

Outcome Measures

Primary Outcomes (1)

• survival rates

  6, 12 months

Secondary Outcomes (1)

• quality of life

  6, 12 months

Study Arms (2)

TACE

ACTIVE COMPARATOR

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

Procedure: transcatheter arterial chemoembolization

control

NO INTERVENTION

best support care

Interventions

transcatheter arterial chemoembolization PROCEDURE

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

Also known as: TACE

TACE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Canter Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.

  PMID: 16250051 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• jinqing li, MD

  cancer canter sun yat-set university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: March 28, 2008
• Study Start: July 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: February 1, 2010
• Last Updated: June 6, 2012

Record last verified: 2012-06

Locations

CN (1)