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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
chemoembolization ,Radiofrequency ablation
Sponsored by
Shandong University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma,treatment

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    overall survival

    Secondary Outcome Measures

    tumor response

    Full Information

    First Posted
    May 24, 2007
    Last Updated
    May 24, 2007
    Sponsor
    Shandong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00479050
    Brief Title
    Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm
    Acronym
    TACE-RFA
    Official Title
    Phase 1 Study of Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Shandong University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatocellular Carcinoma
    Keywords
    Hepatocellular carcinoma,treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    291 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    chemoembolization ,Radiofrequency ablation
    Primary Outcome Measure Information:
    Title
    overall survival
    Time Frame
    5 years
    Secondary Outcome Measure Information:
    Title
    tumor response
    Time Frame
    1-6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wang Qi Liang, MD,PhD
    Organizational Affiliation
    Dept. of Radiology
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18398079
    Citation
    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.
    Results Reference
    derived

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    Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm

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