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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00479050
Recruitment Status : Completed
First Posted : May 25, 2007
Last Update Posted : May 25, 2007
Information provided by:
Shandong University

May 24, 2007
May 25, 2007
May 25, 2007
January 2001
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overall survival [ Time Frame: 5 years ]
Same as current
No Changes Posted
tumor response [ Time Frame: 1-6 months ]
Same as current
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Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm
Phase 1 Study of Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm
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.

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.

Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Hepatocellular Carcinoma
Procedure: chemoembolization ,Radiofrequency ablation
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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. doi: 10.1001/jama.299.14.1669. Retraction in: DeAngelis CD, Fontanarosa PB. JAMA. 2009 May 13;301(18):1931.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2006
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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.
Sexes Eligible for Study: All
45 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Shandong University
Not Provided
Study Chair: Wang Qi Liang, MD,PhD Dept. of Radiology
Shandong University
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP