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Clinical Research of Licartin Combined With TACE in the Treatment of Unresectable Hepatocellular Carcinoma

Primary Purpose

Unresectable Hepatocellular Carcinoma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Licartin
Transcatheter arterial chemoembolization
Sponsored by
Eastern Hepatobiliary Surgery Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. the participation is entirely voluntary, good at compliance, sign the informed consent form in person;
  2. diagnosed to be hepatocellular carcinoma by clinical method, imaging method and tumor markers; and the surgeons determine who can not undergo surgery;
  3. confirmed to recurrent after surgery by pathology;
  4. KPS score of physical state ≥ 60 points;
  5. liver function is Child-Pugh A or B class

Exclusion Criteria:

  1. General situation is poor and liver function Child-Pugh is C class;
  2. there is a serious heart, kidney and blood system diseases in patients;
  3. poor compliance;
  4. there is allergy history of biological agents or in a state of allergy;
  5. pregnancy and breast-feeding women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    control

    therapy

    Arm Description

    Outcomes

    Primary Outcome Measures

    OS of 1 years; TTP

    Secondary Outcome Measures

    Full Information

    First Posted
    December 22, 2008
    Last Updated
    March 30, 2016
    Sponsor
    Eastern Hepatobiliary Surgery Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00829465
    Brief Title
    Clinical Research of Licartin Combined With TACE in the Treatment of Unresectable Hepatocellular Carcinoma
    Official Title
    Clinical Research of in the Treatment of Unresectable Hepatocellular Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2008 (undefined)
    Primary Completion Date
    December 2009 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Eastern Hepatobiliary Surgery Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Liver cancer is a highly invasive malignancy and the rate of surgical resection is no more than 28%. After diagnosis, the average survival rate of patient is less than 50% in 6 month, less than 24% in 1 year and 5% in 5 year. The TACE treatment, under the theoretical basis of blood supply of Liver cancer, is obviously better than the other non-surgical therapy, in terms of tumor regression, AFP decrease, survival time and the evaluation of the quality of life. However, its overall effect is not yet satisfactory. As a result, concerning the research of drug for liver cancer and improving the overall efficacy of the treatment of liver cancer has a very real and important clinical significance and social value. Licartin (Iodine-131-Labeled Metuximab) injection is a antibody drug with new target and the only drug that China own the intellectual property rights. It has specific high affinity with HAb18G/CD147, the liver cell membrane antigen. Labeled 131I is taken to the liver tissue, owning high-dose concentration and releasing β particles to liver cancer cells to and kill cancer cells. The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital, planed to use the treatment of Licartin combined with TACE for the patients of unresectable hepatocellular carcinoma and evaluate the difference of tumor size, AFP change, TTP, the overall survival rate between different treatment group.
    Detailed Description
    Liver cancer is a highly invasive malignancy and the rate of surgical resection is no more than 28%. The TACE treatment, under the theoretical basis of blood supply of Liver cancer, is obviously better than the other non-surgical therapy, in terms of tumor regression, AFP decrease, survival time and the evaluation of the quality of life. Licartin injection is a antibody drug with new target and the only drug that China own the intellectual property rights. It has specific high affinity with HAb18G/CD147, the liver cell membrane antigen. Labeled 131I is taken to the liver tissue, owning high-dose concentration and releasing β particles to liver cancer cells to and kill cancer cells. The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital, planed to use the treatment of Licartin combined with TACE for the patients of unresectable hepatocellular carcinoma and evaluate the difference of tumor size, AFP change, TTP, the overall survival rate between different treatment group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Unresectable Hepatocellular Carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    Active Comparator
    Arm Title
    therapy
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Licartin
    Other Intervention Name(s)
    TACE and Licartin
    Intervention Description
    Licartin
    Intervention Type
    Procedure
    Intervention Name(s)
    Transcatheter arterial chemoembolization
    Intervention Description
    TACE
    Primary Outcome Measure Information:
    Title
    OS of 1 years; TTP
    Time Frame
    2008.12--2010-12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: the participation is entirely voluntary, good at compliance, sign the informed consent form in person; diagnosed to be hepatocellular carcinoma by clinical method, imaging method and tumor markers; and the surgeons determine who can not undergo surgery; confirmed to recurrent after surgery by pathology; KPS score of physical state ≥ 60 points; liver function is Child-Pugh A or B class Exclusion Criteria: General situation is poor and liver function Child-Pugh is C class; there is a serious heart, kidney and blood system diseases in patients; poor compliance; there is allergy history of biological agents or in a state of allergy; pregnancy and breast-feeding women
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yang yefa, doctor
    Organizational Affiliation
    Second Military Medical University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Research of Licartin Combined With TACE in the Treatment of Unresectable Hepatocellular Carcinoma

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