Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm (TACE-RFA)

This study has been completed.
Sponsor:
Information provided by:
Shandong University
ClinicalTrials.gov Identifier:
NCT00479050
First received: May 24, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Phase 1 Study of Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm

Resource links provided by NLM:


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:

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

Exclusion Criteria:

Exclusion criteria were:

  1. Encephalopathy,
  2. Refractory ascites,
  3. Active gastrointestinal bleeding,
  4. 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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00479050     History of Changes
Other Study ID Numbers: 2001HCC, 03BS035
Study First Received: May 24, 2007
Last Updated: May 24, 2007
Health Authority: China: Ethics Committee

Keywords provided by Shandong University:
Hepatocellular carcinoma,treatment

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 17, 2014