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Chemotherapy Combined With CIK Treating Colon Cancer

Primary Purpose

Colorectal Cancer, Cytokine-induced Killer Cells, Postoperative Complications

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cytokine-induced killer cells+ FOLFOX4
FOLFOX4
Sponsored by
China Meitan General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Tumor, Nodes, Metastasis (TNM) stage of II or III;
  2. Patients received radical resection of colon cancer;
  3. Pathological diagnosis of adenocarcinoma;
  4. Patients not received radiotherapy and chemotherapy before surgery;
  5. The preoperative examination confirmed without systemic metastasis;
  6. Patient has the Karnofsky score more than 70 points;
  7. Subjects signed informed consent.

Exclusion Criteria:

  1. Patients who was serious allergy to any of the ingredients of drugs used in this study;
  2. Patients who unable to comply with the treatment plan or research program;
  3. Patients with severe systemic disease that the researchers judged will be unable to complete the study;
  4. Patients have severe heart disease, such as myocardial infarction within 6 months;
  5. Patients who have received chemotherapy or systemic antitumor therapy (such as monoclonal antibody therapy);
  6. Patients received radiotherapy;
  7. Having other malignant tumors in the last 5 years, but not including who has been cured through surgery and survived 5 year of disease-free;
  8. Any unstable systemic diseases (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction, serious arrhythmias, liver, kidney or metabolic diseases within six months).
  9. Patients who do not get effective treatment of inflammation, eye infections or predisposing factors;
  10. Physical examination or laboratory findings evidence reasonable doubt who is ill or use of related drugs could affect the study;
  11. Patients with serious active infections;
  12. Woman who are pregnant or lactating.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Cytokine-induced killer cells + FOLFOX4

    FOLFOX4

    Arm Description

    Cytokine-induced killer cells + FOLFOX4 intervention: Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL 5% dextrose in water (D5W); Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags; Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours.The treatment is given for 4-6 cycles, every 3 weeks. Collected cytokine-induced killer cells (CIK) cells were suspended with 100ml saline (containing 5ml 20% human serum albumin) and given continuously over 2 hours/ day for 3 days.

    FOLFOX4 intervention: Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL 5% dextrose in water (D5W); Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags; Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks.

    Outcomes

    Primary Outcome Measures

    Relapse Free Survival in 2 years

    Secondary Outcome Measures

    Relapse Free Survival in 3 years
    5 year Overall Survival

    Full Information

    First Posted
    March 8, 2017
    Last Updated
    March 14, 2017
    Sponsor
    China Meitan General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03084809
    Brief Title
    Chemotherapy Combined With CIK Treating Colon Cancer
    Official Title
    Clinical Efficacy of Chemotherapy Combined With Cytokine-induced Killer in Treatment of Patients With Colon Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 6, 2012 (Actual)
    Primary Completion Date
    September 15, 2014 (Actual)
    Study Completion Date
    September 15, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China Meitan General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. The investigators aim to evaluate the clinical efficacy of chemotherapy combined with CIK in the treatment of postoperative colorectal cancer patients. And to provide useful reference for the clinical application of CIK in colorectal cancer patients.
    Detailed Description
    Over the past decade, advances in combination chemotherapy regimens for colorectal cancer have led to significant improvement in progression-free and overall survival. Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. Research has demonstrated the median overall survival (OS) in patients received CIK combined with chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4] plan) was significantly increased compared with that in patients received chemotherapy alone. Furthermore, there was a trend toward superior progression-free survival time (PFS) in patients received CIK combined with chemotherapy compared with that in patients received chemotherapy alone. The investigators aim to evaluate the clinical efficacy of chemotherapy (FOLFOX4) combined with CIK in the treatment of postoperative colorectal cancer patients. And to provide useful reference for the clinical application of CIK in colorectal cancer patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer, Cytokine-induced Killer Cells, Postoperative Complications, Survival

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group 1: chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4]) combined with cytokine-induced killer cells (CIK) Group 2: chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4])
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cytokine-induced killer cells + FOLFOX4
    Arm Type
    Experimental
    Arm Description
    Cytokine-induced killer cells + FOLFOX4 intervention: Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL 5% dextrose in water (D5W); Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags; Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours.The treatment is given for 4-6 cycles, every 3 weeks. Collected cytokine-induced killer cells (CIK) cells were suspended with 100ml saline (containing 5ml 20% human serum albumin) and given continuously over 2 hours/ day for 3 days.
    Arm Title
    FOLFOX4
    Arm Type
    Experimental
    Arm Description
    FOLFOX4 intervention: Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL 5% dextrose in water (D5W); Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags; Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Cytokine-induced killer cells+ FOLFOX4
    Other Intervention Name(s)
    CIK + Oxaliplatin + leucovorin + 5-FU
    Intervention Description
    Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL D5W. Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks. Collected CIK cells were suspended with 100ml saline (containing 5ml 20% human serum albumin) and given continuously over 2 hours/ day for 3 days.
    Intervention Type
    Drug
    Intervention Name(s)
    FOLFOX4
    Other Intervention Name(s)
    Oxaliplatin + leucovorin + 5-FU
    Intervention Description
    Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL D5W. Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks.
    Primary Outcome Measure Information:
    Title
    Relapse Free Survival in 2 years
    Time Frame
    2 years (24 months)
    Secondary Outcome Measure Information:
    Title
    Relapse Free Survival in 3 years
    Time Frame
    Follow-up: 3 years
    Title
    5 year Overall Survival
    Time Frame
    Follow-up: 5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    78 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Tumor, Nodes, Metastasis (TNM) stage of II or III; Patients received radical resection of colon cancer; Pathological diagnosis of adenocarcinoma; Patients not received radiotherapy and chemotherapy before surgery; The preoperative examination confirmed without systemic metastasis; Patient has the Karnofsky score more than 70 points; Subjects signed informed consent. Exclusion Criteria: Patients who was serious allergy to any of the ingredients of drugs used in this study; Patients who unable to comply with the treatment plan or research program; Patients with severe systemic disease that the researchers judged will be unable to complete the study; Patients have severe heart disease, such as myocardial infarction within 6 months; Patients who have received chemotherapy or systemic antitumor therapy (such as monoclonal antibody therapy); Patients received radiotherapy; Having other malignant tumors in the last 5 years, but not including who has been cured through surgery and survived 5 year of disease-free; Any unstable systemic diseases (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction, serious arrhythmias, liver, kidney or metabolic diseases within six months). Patients who do not get effective treatment of inflammation, eye infections or predisposing factors; Physical examination or laboratory findings evidence reasonable doubt who is ill or use of related drugs could affect the study; Patients with serious active infections; Woman who are pregnant or lactating.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Li-Min Wang, Dr.
    Organizational Affiliation
    Center for Drug Evaluation, China food and Drug Administration
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    whether individual participant data (IPD) could be shared must obtain the consent of the subjects

    Learn more about this trial

    Chemotherapy Combined With CIK Treating Colon Cancer

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