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

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ClinicalTrials.gov Identifier: NCT00479050
Recruitment Status : Completed
First Posted : May 25, 2007
Last Update Posted : May 25, 2007
Sponsor:
Information provided by:
Shandong University

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: chemoembolization ,Radiofrequency ablation Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Phase 1 Study of Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm
Study Start Date : January 2001
Actual Study Completion Date : December 2006



Primary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. tumor response [ Time Frame: 1-6 months ]


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479050


Sponsors and Collaborators
Shandong University
Investigators
Study Chair: Wang Qi Liang, MD,PhD Dept. of Radiology

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
First Posted: May 25, 2007    Key Record Dates
Last Update Posted: May 25, 2007
Last Verified: May 2007

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