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The Study of CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer

Primary Purpose

Colorectal Neoplasms

Status
Active
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cytokine-Induced Killer Cells
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 Colorectal Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who can accept curative operations 18-70 years old
  • Histologically confirmed with colorectal 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

    Experimental

    No Intervention

    Arm Label

    CIK plus S-1 and Bevacizumab

    S-1 and Bevacizumab

    Arm Description

    Cytokine-Induced Killer Cells are used to treat advanced colorectal cancer patients with S-1 and Bevacizumab. S-1, 60mg,p.o.,Bid,d2-15. Bevacizumab (Avastin),7.5mg/kg,ivgtt,d1. 3 weeks is a cycle. Continue until the disease progress. Cytokine-induced killer cells 3 cycles,every 1 year. Continue until the disease progress.

    S-1 is an oral anticancer agent, is a derivative of fluorouracil. Bevacizumab (Avastin) is a recombinant human monoclonal IgG1 antibody, which plays a role in the biological activity of human vascular endothelial growth factor. Bevacizumab is mainly used in the treatment of advanced colorectal cancer. S-1, 60mg,p.o.,Bid,d2-15. Bevacizumab (Avastin),7.5mg/kg,ivgtt,d1. 3 weeks is a cycle. Continue until the disease progress.

    Outcomes

    Primary Outcome Measures

    Overall Survival(OS)

    Secondary Outcome Measures

    Disease-free survival

    Full Information

    First Posted
    June 30, 2015
    Last Updated
    February 23, 2016
    Sponsor
    The First People's Hospital of Changzhou
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02487992
    Brief Title
    The Study of CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer
    Official Title
    The Randomized, Controlled, Multicenter Clinical Trial of CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    July 2043 (Anticipated)
    Study Completion Date
    July 2045 (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 cytokine-induced killer cell (CIK) plus S-1 and Bevacizumab vs S-1 and Bevacizumab as Maintenance Treatment for patients with advanced colorectal cancer.
    Detailed Description
    1200 patients with stage Ⅳ colorectal cancer,who had received surgery and chemotherapy,will be randomly divided into group A（receive CIK plus S-1 and Bevacizumab ) or group B（just receive S-1 and Bevacizumab),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 S-1 and Bevacizumab (continuous) .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Neoplasms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CIK plus S-1 and Bevacizumab
    Arm Type
    Experimental
    Arm Description
    Cytokine-Induced Killer Cells are used to treat advanced colorectal cancer patients with S-1 and Bevacizumab. S-1, 60mg,p.o.,Bid,d2-15. Bevacizumab (Avastin),7.5mg/kg,ivgtt,d1. 3 weeks is a cycle. Continue until the disease progress. Cytokine-induced killer cells 3 cycles,every 1 year. Continue until the disease progress.
    Arm Title
    S-1 and Bevacizumab
    Arm Type
    No Intervention
    Arm Description
    S-1 is an oral anticancer agent, is a derivative of fluorouracil. Bevacizumab (Avastin) is a recombinant human monoclonal IgG1 antibody, which plays a role in the biological activity of human vascular endothelial growth factor. Bevacizumab is mainly used in the treatment of advanced colorectal cancer. S-1, 60mg,p.o.,Bid,d2-15. Bevacizumab (Avastin),7.5mg/kg,ivgtt,d1. 3 weeks is a cycle. Continue until the disease progress.
    Intervention Type
    Biological
    Intervention Name(s)
    Cytokine-Induced Killer Cells
    Intervention Description
    CIK cells transfected with cytokine genes possess an improved proliferation rate and a higher cytotoxic activity as compared to regular CIK cells.
    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
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who can accept curative operations 18-70 years old Histologically confirmed with colorectal 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 CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer

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