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CIK in Treating Patients With Esophageal Cancer

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Not yet recruiting
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 Esophageal Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients histologically confirmed esophageal carcinoma;
  • Patients with staging I-III of esophageal carcinoma;
  • Patients who had completed chemotherapy;
  • Patients who have a life expectancy of at least 12 weeks;
  • Eastern Cooperative Oncology Group (ECOG) performance status was 0-1;
  • The bone marrow functioned normally (WBC>4.0×10^9/L, Hb>120 g/L, Platelet(PLT)>100×10^9/L);
  • The ECG results were normal, and the liver and kidney were functional.

Exclusion Criteria:

  • Patients who had distant metastases by imaging studies;
  • Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
  • Patients who were lactating;
  • ECOG perform status ≥ 2;
  • Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment;
  • Patients who are pregnant or nursing;
  • Patients with active tuberculosis (highly positive skin tests allowed if no active disease);
  • Patients with disease that would preclude general anesthesia;
  • Patients with active intractable or uncontrollable infection.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    No-CIK

    CIK

    Arm Description

    After accepting chemotherapy, patients will regularly follow up.

    After accepting chemotherapy, patients will receive at least 3 cycles of Cytokine-induced Killer Cells treatment per year

    Outcomes

    Primary Outcome Measures

    progression-free survival(PFS)

    Secondary Outcome Measures

    overall survival(OS)

    Full Information

    First Posted
    July 2, 2015
    Last Updated
    July 2, 2015
    Sponsor
    The First People's Hospital of Changzhou
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02490735
    Brief Title
    CIK in Treating Patients With Esophageal Cancer
    Official Title
    A Randomized Controlled Study of Cytokine-induced Killer Cells (CIK) Treatment in Patients With Staging Ⅰ-Ⅲ of Esophageal Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    August 2040 (Anticipated)
    Study Completion Date
    August 2042 (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
    Yes

    5. Study Description

    Brief Summary
    Chemotherapy is the main treatment method for patients with Esophageal Cancer. However, Relapse remains the major cause of treatment failure.Biological therapies such as CIK stimulate the immune system and stop tumor cells from growing. A series of studies reported that cytokine-induced killer cells (CIK) have a broad anti-tumor spectrum. The investigators suppose that CIK will improve the prognosis. Combining chemotherapy with biological therapy may kill more tumor cells. In this study, the patients will be treated with CIK cells after chemotherapy. The purpose of this study is to evaluate the efficacy of CIK for Esophageal Cancer.
    Detailed Description
    About 2000 patients with staging I-III of Esophageal Cancer, after accepting chemotherapy, will be randomly divided into group A (receive CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK cells treatment (every 12 weeks). Patients in group B will have no anti-tumor therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Squamous Cell Carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    No-CIK
    Arm Type
    No Intervention
    Arm Description
    After accepting chemotherapy, patients will regularly follow up.
    Arm Title
    CIK
    Arm Type
    Experimental
    Arm Description
    After accepting chemotherapy, patients will receive at least 3 cycles of Cytokine-induced Killer Cells treatment per year
    Intervention Type
    Biological
    Intervention Name(s)
    Cytokine-induced Killer Cells
    Other Intervention Name(s)
    CIK
    Intervention Description
    chemotherapy plus 3 cycles of Cytokine-induced Killer Cells(CIK) treatment
    Primary Outcome Measure Information:
    Title
    progression-free survival(PFS)
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    overall survival(OS)
    Time Frame
    1 month
    Other Pre-specified Outcome Measures:
    Title
    Stage at diagnosis
    Description
    Tumor Node Metastasis (TNM) stage, Tumor:CIS,T1,T2,T3,T4 according to the depth of tumor invasion. Lymph node involvement: N0,N1,N2. Metastasis: M0,M1
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients histologically confirmed esophageal carcinoma; Patients with staging I-III of esophageal carcinoma; Patients who had completed chemotherapy; Patients who have a life expectancy of at least 12 weeks; Eastern Cooperative Oncology Group (ECOG) performance status was 0-1; The bone marrow functioned normally (WBC>4.0×10^9/L, Hb>120 g/L, Platelet(PLT)>100×10^9/L); The ECG results were normal, and the liver and kidney were functional. Exclusion Criteria: Patients who had distant metastases by imaging studies; Patients with uncontrolled infection; underlying disease that was severe or life-threatening; Patients who were lactating; ECOG perform status ≥ 2; Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment; Patients who are pregnant or nursing; Patients with active tuberculosis (highly positive skin tests allowed if no active disease); Patients with disease that would preclude general anesthesia; Patients with active intractable or uncontrollable infection.

    12. IPD Sharing Statement

    Learn more about this trial

    CIK in Treating Patients With Esophageal Cancer

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