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

This study has been completed.
Information provided by Shandong University

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Descriptive Information Fields
Brief Title  Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm
Official Title  Phase 1 Study of Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm
Brief Summary

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.

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.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure  overall survival [ Time Frame: 5 years ]
Secondary Outcome Measure  tumor response [ Time Frame: 1-6 months ]
Condition  Hepatocellular Carcinoma
Intervention  Procedure: chemoembolization ,Radiofrequency ablation
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  291
Start Date  January 2001
Completion Date December 2006
Eligibility 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.
Gender Both
Ages 45 Years to 75 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00479050
Organization ID 2001HCC
Secondary IDs †† 03BS035
Study Sponsor  Shandong University
Collaborators ††
Investigators 
Study Chair:     Wang Qi Liang, MD,PhD     Dept of radiology    
Information Provided By Shandong University
Verification Date May 2007
First Received Date  May 24, 2007
Last Updated Date May 24, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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