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The Study of Apatinib Plus CIK as the Third Line Therapy for Patients With Advanced Gastric Cancer

Primary Purpose

Stomach Neoplasms

Status
Active
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cytokine-Induced Killer Cells
Apatinib
Sponsored by
The First People's Hospital of Changzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring CIK, gastric cancer, Apatinib

Eligibility Criteria

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

Inclusion Criteria:

  • Patients who can accept curative operations 18-70 years old
  • Histologically confirmed with gastric cancer at stage Ⅳ
  • Patients who can accept oral drugs;
  • Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.

Exclusion Criteria:

  • Hemoglobin<8.0 g/dL,White blood cell <3 X 10^9/L;Platelet count <75 X 10^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial
  • Pregnant or lactating patients
  • Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
  • Patients who are suffering from serious autoimmune disease
  • Patients who had used long time or are using immunosuppressant
  • Patients who had active infection
  • Patients who are suffering from serious organ dysfunction
  • Patients who are suffering from other cancer
  • Other situations that the researchers considered unsuitable for this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Apatinib alone

    Apatinib+CIK

    Arm Description

    Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.Patients undergo Apatinib.

    Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.

    Outcomes

    Primary Outcome Measures

    Overall Survival(OS)

    Secondary Outcome Measures

    Disease-free survival

    Full Information

    First Posted
    June 24, 2015
    Last Updated
    February 18, 2016
    Sponsor
    The First People's Hospital of Changzhou
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02485015
    Brief Title
    The Study of Apatinib Plus CIK as the Third Line Therapy for Patients With Advanced Gastric Cancer
    Official Title
    The Randomized, Controlled, Multicenter Clinical Trial of Apatinib Plus CIK as the Third Line Therapy for Patients With Advanced Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    June 2030 (Anticipated)
    Study Completion Date
    June 2033 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First People's Hospital of Changzhou

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with cytokine-induced killer cell (CIK) vs Apatinib as the third line therapy for patients with advanced gastric cancer.
    Detailed Description
    400 patients with stage Ⅳ Gastric Cancer,who had received surgery and chemotherapy,will be randomly divided into group A（receive Apatinib and CIK treatment ) or group B（just receive Apatinib),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only Apatinib (continuous) .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stomach Neoplasms
    Keywords
    CIK, gastric cancer, Apatinib

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Apatinib alone
    Arm Type
    Other
    Arm Description
    Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.Patients undergo Apatinib.
    Arm Title
    Apatinib+CIK
    Arm Type
    Experimental
    Arm Description
    Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.
    Intervention Type
    Biological
    Intervention Name(s)
    Cytokine-Induced Killer Cells
    Other Intervention Name(s)
    CIK
    Intervention Description
    Cytokine-Induced Killer Cells are used to treat advanced gastric cancer patients with Apatinib.
    Intervention Type
    Drug
    Intervention Name(s)
    Apatinib
    Other Intervention Name(s)
    YN968D1
    Intervention Description
    Advanced gastric cancer patients take Apatinib 850mg qd by mouth.
    Primary Outcome Measure Information:
    Title
    Overall Survival(OS)
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Disease-free survival
    Time Frame
    3 months
    Other Pre-specified Outcome Measures:
    Title
    Adverse events
    Time Frame
    1 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who can accept curative operations 18-70 years old Histologically confirmed with gastric cancer at stage Ⅳ Patients who can accept oral drugs; Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1. Exclusion Criteria: Hemoglobin<8.0 g/dL,White blood cell <3 X 10^9/L;Platelet count <75 X 10^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times Known or suspected allergy to the investigational agent or any agent given in association with this trial Pregnant or lactating patients Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection Patients who are suffering from serious autoimmune disease Patients who had used long time or are using immunosuppressant Patients who had active infection Patients who are suffering from serious organ dysfunction Patients who are suffering from other cancer Other situations that the researchers considered unsuitable for this study.

    12. IPD Sharing Statement

    Learn more about this trial

    The Study of Apatinib Plus CIK as the Third Line Therapy for Patients With Advanced Gastric Cancer

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