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Combined Therapy for Hepatocellular Carcinoma >3-<5 cm

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Combined therapy
Microwave ablation
Transarterial chemoembolization
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Combined therapy; hepatocellular carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Solitary HCC >3-<5 cm
  2. Absence of extra-hepatic metastases
  3. Absence of a history of encephalopathy or refractory ascites
  4. Child-Pugh class A or B cirrhosis.

Exclusion Criteria:

  1. Poor patient compliance
  2. Child-Pugh class C cirrhosis
  3. Severe coagulation disorders
  4. Portal vein thrombosis
  5. Renal impairment (6) previous local ablation therapy of HCC

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Combined therapy

    Transarterial chemoembolization

    Microwave ablation

    Arm Description

    Patients undergoing combined therapy

    Patients undergoing Transarterial chemoembolization

    Patients undergoing Microwave ablation

    Outcomes

    Primary Outcome Measures

    Adverse events
    Images were evaluated and compared for adverse events. The adverse events were recorded and classified following the guidelines of the Society of Interventional Radiology
    Treatment Response
    Tumor response was evaluated by CECT or dynamic MRI based on the modified response evaluation criteria in solid tumor (m-RECIST) established by the American Association for the Study of Liver Diseases.
    Recurrence rate
    The recurrence rate was measured in relation to management lines.
    Overall mortality rate
    The mortality rate was measured in relation to management lines.
    Progression-free survival
    The progression-free survival was measured in relation to management lines.
    AFP variation rate
    The AFP variation rate (ΔAFP) was defined as the percentage of change between the AFP concentration at baseline and the postprocedure AFP concentration after 1-2 months as shown in the following equation: ΔAFP (%) = [(AFPbaseline-AFPpostprocedure) /AFPbaseline] ×100%

    Secondary Outcome Measures

    Full Information

    First Posted
    January 20, 2021
    Last Updated
    January 21, 2021
    Sponsor
    Zagazig University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04721470
    Brief Title
    Combined Therapy for Hepatocellular Carcinoma >3-<5 cm
    Official Title
    Combined Therapy With Conventional Trans-arterial Chemoembolization (cTACE) and Microwave Ablation (MWA) for Hepatocellular Carcinoma >3-<5 cm
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    May 15, 2020 (Actual)
    Study Completion Date
    October 20, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zagazig University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the safety and efficacy of combined therapy with conventional transarterial chemoembolization (cTACE) + microwave ablation (MWA) versus only TACE or MWA for treatment of hepatocellular carcinoma (HCC) >3-<5 cm.
    Detailed Description
    This study aims to compare the safety and efficacy of combined therapy with conventional transarterial chemoembolization (cTACE)+microwave ablation (MWA) versus only TACE or MWA for treatment of hepatocellular carcinoma (HCC) >3-<5 cm. This randomized controlled trial screened 278 patients with HCC >3-<5 cm. Patients were randomized into three groups: 90 underwent TACE (Group 1); 95 underwent MWA (Group 2); and 93 underwent combined therapy (Group 3). Patients were followed-up with contrast-enhanced CT or MRI. Images were evaluated and compared for treatment response and adverse events based on modified response evaluation criteria in solid tumor. Serum alpha-fetoprotein (AFP) concentration was measured at baseline and during every follow-up visit.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatocellular Carcinoma
    Keywords
    Combined therapy; hepatocellular carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients were randomized into three groups: 90 underwent TACE (Group 1); 95 underwent MWA (Group 2); and 93 underwent combined therapy (Group 3).
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    278 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Combined therapy
    Arm Type
    Experimental
    Arm Description
    Patients undergoing combined therapy
    Arm Title
    Transarterial chemoembolization
    Arm Type
    Active Comparator
    Arm Description
    Patients undergoing Transarterial chemoembolization
    Arm Title
    Microwave ablation
    Arm Type
    Active Comparator
    Arm Description
    Patients undergoing Microwave ablation
    Intervention Type
    Procedure
    Intervention Name(s)
    Combined therapy
    Other Intervention Name(s)
    Transarterial chemoembolization + Microwave ablation
    Intervention Description
    Patients undergoing combined therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    Microwave ablation
    Intervention Description
    Patients undergoing Microwave ablation
    Intervention Type
    Procedure
    Intervention Name(s)
    Transarterial chemoembolization
    Intervention Description
    Patients undergoing Transarterial chemoembolization
    Primary Outcome Measure Information:
    Title
    Adverse events
    Description
    Images were evaluated and compared for adverse events. The adverse events were recorded and classified following the guidelines of the Society of Interventional Radiology
    Time Frame
    Up to three years after procedure
    Title
    Treatment Response
    Description
    Tumor response was evaluated by CECT or dynamic MRI based on the modified response evaluation criteria in solid tumor (m-RECIST) established by the American Association for the Study of Liver Diseases.
    Time Frame
    One month
    Title
    Recurrence rate
    Description
    The recurrence rate was measured in relation to management lines.
    Time Frame
    12 months after procedure
    Title
    Overall mortality rate
    Description
    The mortality rate was measured in relation to management lines.
    Time Frame
    Three years after procedure
    Title
    Progression-free survival
    Description
    The progression-free survival was measured in relation to management lines.
    Time Frame
    Three years after procedure
    Title
    AFP variation rate
    Description
    The AFP variation rate (ΔAFP) was defined as the percentage of change between the AFP concentration at baseline and the postprocedure AFP concentration after 1-2 months as shown in the following equation: ΔAFP (%) = [(AFPbaseline-AFPpostprocedure) /AFPbaseline] ×100%
    Time Frame
    Baseline and 1-2 months after procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Solitary HCC >3-<5 cm Absence of extra-hepatic metastases Absence of a history of encephalopathy or refractory ascites Child-Pugh class A or B cirrhosis. Exclusion Criteria: Poor patient compliance Child-Pugh class C cirrhosis Severe coagulation disorders Portal vein thrombosis Renal impairment (6) previous local ablation therapy of HCC
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammad A Basha, Professor
    Organizational Affiliation
    Zagazig University, Egypt
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33615957
    Citation
    Zaitoun MMA, Elsayed SB, Zaitoun NA, Soliman RK, Elmokadem AH, Farag AA, Amer M, Hendi AM, Mahmoud NEM, Salah El Deen D, Alsowey AM, Shahin S, Basha MAA. Combined therapy with conventional trans-arterial chemoembolization (cTACE) and microwave ablation (MWA) for hepatocellular carcinoma >3-<5 cm. Int J Hyperthermia. 2021;38(1):248-256. doi: 10.1080/02656736.2021.1887941.
    Results Reference
    derived

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    Combined Therapy for Hepatocellular Carcinoma >3-<5 cm

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