Transarterial Chemoembolization for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

Hepatocellular Carcinoma Clinical Trial

— TACEHCC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646100
• Other study ID #: TACE1
• Status: Completed
• Phase: Phase 4
• First received: March 25, 2008
• Last updated: June 5, 2012
• Start date: July 2007
• Est. completion date: February 2010

Study information

• Verified date: June 2012
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: February 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• transcatheter arterial chemoembolization
chemo-lipiodolization with EADM 50mg, Lobaplatin 50mg, and MMC 6mg,plus particleembolization.

Locations

Country	Name	City	State
China	Cancer Canter Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rates		6, 12 months	Yes
Secondary	quality of life		6, 12 months	Yes