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Treatment Patients With Pulmonary Metastasis of Liver Cancer With Apatinib Combination With TACE: a Clinical Study

Primary Purpose

Hepatocellular Carcinoma, Pulmonary Metastasis

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Apatinib
TACE
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, pulmonary metastasis, Apatinib, efficacy, safety

Eligibility Criteria

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

Inclusion Criteria:

  • clinical diagnosis of hepatocellular carcinoma
  • refused to sorafenib treatment
  • have at least one measurable pulmonary lesions
  • expected survival time ≥ 12 weeks

Exclusion Criteria:

  • within four weeks before the study received radiotherapy or chemotherapy
  • With a variety of factors influencing oral drugs taking and absorption (such as unable to swallow, chronic diarrhea and intestinal obstruction)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Apatinib & TACE

    TACE

    Arm Description

    Apatinib 500mg tablet by mouth per day, until disease progression, combined with TACE therapy one times every 4-6 weeks.

    TACE therapy one times every 4-6 weeks.

    Outcomes

    Primary Outcome Measures

    Progress Free Survival
    PFS is defined as the months that from the anticipation of the clinical-trial to the progress of hepatocellular cancer

    Secondary Outcome Measures

    overall survival
    OS is defined as the months that from the anticipation of the clinical-trial to the death of patients.
    Objective response rate
    Time to progress of lung lesions which was confirmed by CT/MRI
    The Quality of Life
    Toxicity as measured by CTCAE V4.0

    Full Information

    First Posted
    February 21, 2016
    Last Updated
    March 2, 2016
    Sponsor
    Zhejiang Cancer Hospital
    Collaborators
    First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital, School of Medicine, Zhejiang University, The Central Hospital of Lishui City, First Affiliated Hospital of Wenzhou Medical University, Ningbo No.2 Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02702323
    Brief Title
    Treatment Patients With Pulmonary Metastasis of Liver Cancer With Apatinib Combination With TACE: a Clinical Study
    Official Title
    Treatment Patients With Pulmonary Metastasis of Liver Cancer With Apatinib Combination With TACE: a Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    March 2018 (Anticipated)
    Study Completion Date
    March 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zhejiang Cancer Hospital
    Collaborators
    First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital, School of Medicine, Zhejiang University, The Central Hospital of Lishui City, First Affiliated Hospital of Wenzhou Medical University, Ningbo No.2 Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study mainly evaluate the clinical effect of Apatinib in the treatment of patients with pulmonary metastasis of hepatocellular carcinoma.Half of participants will receive Apatinib and transcatheter arterial chemoembolization (TACE) therapy in combination,while the other half will receive TACE therapy alone.
    Detailed Description
    Apatinib is a VEGFR targeting tyrosine kinase inhibitor, which has preliminary demonstrated the efficacy and safety in treatment of advanced hepatocellular carcinoma by phase II stage research. Pulmonary metastasis of hepatocellular cancer is one of the difficulties in clinical practice,because it's not sensitive to systemic chemotherapy.This phase Ⅲ study aims to evaluates the efficacy and safety of the Apatinib in the treatment of advanced hepatocellular cancer with pulmonary metastasis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatocellular Carcinoma, Pulmonary Metastasis
    Keywords
    hepatocellular carcinoma, pulmonary metastasis, Apatinib, efficacy, safety

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Apatinib & TACE
    Arm Type
    Experimental
    Arm Description
    Apatinib 500mg tablet by mouth per day, until disease progression, combined with TACE therapy one times every 4-6 weeks.
    Arm Title
    TACE
    Arm Type
    Active Comparator
    Arm Description
    TACE therapy one times every 4-6 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Apatinib
    Intervention Description
    apatinib 500mg/day for 6 weeks began taking 4-7 days after TACE
    Intervention Type
    Procedure
    Intervention Name(s)
    TACE
    Other Intervention Name(s)
    transcatheter arterial chemoembolization
    Intervention Description
    one times every 4-6 weeks.
    Primary Outcome Measure Information:
    Title
    Progress Free Survival
    Description
    PFS is defined as the months that from the anticipation of the clinical-trial to the progress of hepatocellular cancer
    Time Frame
    Change from Baseline mRECIST at 12 months was assessed every 4 weeks up to 48 weeks. Data collection is from date of randomization until the date of first documented progression assessed up to 12 months.
    Secondary Outcome Measure Information:
    Title
    overall survival
    Description
    OS is defined as the months that from the anticipation of the clinical-trial to the death of patients.
    Time Frame
    Survival assessed every 4 weeks up to 24 months following objective disease progression. Data collection is from date of randomization until the date of death from any cause, assessed up to 48 months.
    Title
    Objective response rate
    Description
    Time to progress of lung lesions which was confirmed by CT/MRI
    Time Frame
    1 month post intervention
    Title
    The Quality of Life
    Time Frame
    0 to 24 months post intervention
    Title
    Toxicity as measured by CTCAE V4.0
    Time Frame
    0 to 24 months post intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: clinical diagnosis of hepatocellular carcinoma refused to sorafenib treatment have at least one measurable pulmonary lesions expected survival time ≥ 12 weeks Exclusion Criteria: within four weeks before the study received radiotherapy or chemotherapy With a variety of factors influencing oral drugs taking and absorption (such as unable to swallow, chronic diarrhea and intestinal obstruction)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    guoliang shao, phD
    Phone
    +86 13958183472
    Email
    shaoguoliang2008@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    liwen guo, MD
    Phone
    +86 18329130398
    Email
    guoliwen2008@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    guoliang shao, phD
    Organizational Affiliation
    Zhejiang Cancer Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment Patients With Pulmonary Metastasis of Liver Cancer With Apatinib Combination With TACE: a Clinical Study

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