Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm - Full Text View

Sponsored by:	Shandong University
Information provided by:	Shandong University
ClinicalTrials.gov Identifier:	NCT00479050

Purpose

Combined the chemoembolization and Radiofrequency ablation for the hepatocellular carcinoma greater than 3 cm,the ablation volume of coagulation necrosis can be significantly increased,which may be enable effective treatment of patients with HCC greater than 3 cm.

Condition	Intervention	Phase
Hepatocellular Carcinoma	Procedure: chemoembolization ,Radiofrequency ablation	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 1 Study of Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm

Further study details as provided by Shandong University:

Primary Outcome Measures:

overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures:

tumor response [ Time Frame: 1-6 months ]

Enrollment:	291
Study Start Date:	January 2001
Study Completion Date:	December 2006

Detailed Description:

To assess whether the effectiveness of a combination of transcatheter arterial chemoembolization(TACE) and radiofrequency ablation(RFA) is superior to TACE and RFA alone in treatment of patients with hepatocellular carcinoma(HCC)greater than 3 cm and to analyze the factors affecting the outcomes.

The patients with HCC of 3 or fewer lesions, each 3cm greater in diameter entered this randomized controlled trial. The primary end point was survival, and the secondary end points were tumor response.

Eligibility

Ages Eligible for Study:	45 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Eligibility criteria were:

Not indicated for resection,
Liver function of Child-Pugh class A or B,
3 or fewer lesion, each 3 cm greater and 7.5 cm less in greatest diameter,
No portal vein involvement or extrahepatic metastasis,
Lesions located at least 5mm away from the hepatic hilum or gall bladder and the common bile duct,
Platelet count≥6.0×103/mm3 and the prothrombin activity≥60%, and
No previous HCC treatment.

Exclusion Criteria:

Exclusion criteria were:

Encephalopathy,
Refractory ascites,
Active gastrointestinal bleeding,
Renal failure.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479050

Sponsors and Collaborators

Shandong University

Investigators

Study Chair:

Wang Qi Liang, MD,PhD

Dept. of Radiology

More Information

No publications provided by Shandong University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Cheng BQ, Jia CQ, Liu CT, Fan W, Wang QL, Zhang ZL, Yi CH. Chemoembolization combined with radiofrequency ablation for patients with hepatocellular carcinoma larger than 3 cm: a randomized controlled trial. JAMA. 2008 Apr 9;299(14):1669-77.

Study ID Numbers:	2001HCC, 03BS035
Study First Received:	May 24, 2007
Last Updated:	May 24, 2007
ClinicalTrials.gov Identifier:	NCT00479050 History of Changes
Health Authority:	China: Ethics Committee

Keywords provided by Shandong University:

Hepatocellular carcinoma,treatment

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular

Gastrointestinal Neoplasms
Hepatocellular Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Liver Neoplasms
Liver Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

Neoplasms by Histologic Type
Carcinoma, Hepatocellular
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on July 02, 2009