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Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma

Primary Purpose

Liver Cancer, Hepatocellular Carcinoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
LT
ADV-TK
ganciclovir
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring hepatocellular carcinoma, liver transplantation, adenovirus-thymidine kinase, gene therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18～70 years of age (Male and Female).
  • Clinical diagnosis of advanced hepatocellular carcinoma who could accept liver transplantation
  • Patients who had unresectable HCC >5 cm and no metastasis in lungs and bones were eligible to participate in this study. Tumor involvement in the intrahepatic and extrahepatic portal branches was not considered to be an exclusion criterion.
  • No prior chemotherapy, radiation therapy, targeted therapy or other kind of biological treatment within 4 weeks.
  • Provide written informed consent

Exclusion Criteria:

  • Metastasis in lungs and bones
  • Invasion in main vescular.
  • Contraindications of liver transplantation
  • Contraindications of operation of other organ system
  • Hypersensitivity to adenovirus, GCV or similar drugs
  • Accept clinical trials of other drugs
  • Immunological deficit
  • Active pregnancy
  • Unable or unwilling to sign informed consents

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    LT+ADV-TK

    LT

    Arm Description

    Liver transplantation and double-dose ADV-TK/ganciclovir administration The first ADV-TK dose was administered before closing the peritoneal layer; the second ADV-TK dose was administered 2 months after LT; ganciclovir was slowly administered 36 hours after LT and twice daily for 14 days.

    Orthotopic liver transplantation

    Outcomes

    Primary Outcome Measures

    Overall survival rate
    Recurrence-free survival rate

    Secondary Outcome Measures

    Full Information

    First Posted
    July 26, 2014
    Last Updated
    July 28, 2014
    Sponsor
    Huazhong University of Science and Technology
    Collaborators
    Beijing YouAn Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02202564
    Brief Title
    Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2006 (undefined)
    Primary Completion Date
    October 2011 (Actual)
    Study Completion Date
    August 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Huazhong University of Science and Technology
    Collaborators
    Beijing YouAn Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    HCC patients with tumors >5 cm in diameter, regardless of involvement in the intrahepatic and extrahepatic portal branches participated in the study. Patients were randomized allocated in liver transplantation (LT) only group and LT plus ADV-TK therapy group. All patients received orthotopic liver transplantation; in the LT plus ADV-TK group, ADV-TK therapy was delivered to patients twice.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Cancer, Hepatocellular Carcinoma
    Keywords
    hepatocellular carcinoma, liver transplantation, adenovirus-thymidine kinase, gene therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    81 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LT+ADV-TK
    Arm Type
    Experimental
    Arm Description
    Liver transplantation and double-dose ADV-TK/ganciclovir administration The first ADV-TK dose was administered before closing the peritoneal layer; the second ADV-TK dose was administered 2 months after LT; ganciclovir was slowly administered 36 hours after LT and twice daily for 14 days.
    Arm Title
    LT
    Arm Type
    Active Comparator
    Arm Description
    Orthotopic liver transplantation
    Intervention Type
    Procedure
    Intervention Name(s)
    LT
    Other Intervention Name(s)
    liver transplantation
    Intervention Description
    Orthotopic LT
    Intervention Type
    Drug
    Intervention Name(s)
    ADV-TK
    Other Intervention Name(s)
    adenovirus-thymidine kinase
    Intervention Type
    Drug
    Intervention Name(s)
    ganciclovir
    Primary Outcome Measure Information:
    Title
    Overall survival rate
    Time Frame
    up to 3-year
    Title
    Recurrence-free survival rate
    Time Frame
    up to 3-year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18～70 years of age (Male and Female). Clinical diagnosis of advanced hepatocellular carcinoma who could accept liver transplantation Patients who had unresectable HCC >5 cm and no metastasis in lungs and bones were eligible to participate in this study. Tumor involvement in the intrahepatic and extrahepatic portal branches was not considered to be an exclusion criterion. No prior chemotherapy, radiation therapy, targeted therapy or other kind of biological treatment within 4 weeks. Provide written informed consent Exclusion Criteria: Metastasis in lungs and bones Invasion in main vescular. Contraindications of liver transplantation Contraindications of operation of other organ system Hypersensitivity to adenovirus, GCV or similar drugs Accept clinical trials of other drugs Immunological deficit Active pregnancy Unable or unwilling to sign informed consents
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ding Ma, M.D.
    Organizational Affiliation
    Huazhong University of Science and Technology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma

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