search
Back to results

Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Ovarian Carcinoma

Primary Purpose

Ovarian Carcinoma

Status
Active
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Radiofrequency ablation
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 Ovarian Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  1. patients diagnosed with FIGO stage II ovarian carcinoma;
  2. cytoreductive surgery performed and 6 courses of platinum-based chemotherapy completed;
  3. medical records maintain comprehensive data on treatment and follow-up;
  4. no history of previous malignancies.

Exclusion Criteria:

  1. neoadjuvant chemotherapy applied;
  2. less than 6 courses of chemotherapy or more than 6 courses of chemotherapy completed;
  3. medical records maintain incomplete data on treatment or follow-up;
  4. history of previous malignancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    RFA alone

    RFA+CIK

    Arm Description

    Patients undergo radiofrequency ablation alone.

    Autologous cytokine-induced killer cells were transfer via venous one week after RFA Interventions

    Outcomes

    Primary Outcome Measures

    Recurrence-free survival
    Recurrence-free survival (RFS) was defined as the time from the date of RFA to the date of recurrence or the date of the last follow-up.

    Secondary Outcome Measures

    Adverse events
    Adverse events related to RFA and CIK treatments.

    Full Information

    First Posted
    June 29, 2015
    Last Updated
    February 21, 2016
    Sponsor
    The First People's Hospital of Changzhou
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02487693
    Brief Title
    Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Ovarian Carcinoma
    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
    June 2038 (Anticipated)
    Study Completion Date
    June 2040 (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
    The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with ovarian carcinoma.
    Detailed Description
    The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with ovarian carcinoma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Carcinoma

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    RFA alone
    Arm Type
    No Intervention
    Arm Description
    Patients undergo radiofrequency ablation alone.
    Arm Title
    RFA+CIK
    Arm Type
    Experimental
    Arm Description
    Autologous cytokine-induced killer cells were transfer via venous one week after RFA Interventions
    Intervention Type
    Procedure
    Intervention Name(s)
    Radiofrequency ablation
    Other Intervention Name(s)
    RFA
    Intervention Description
    Radiofrequency ablation is performed percutaneously under CT/US guidance
    Intervention Type
    Biological
    Intervention Name(s)
    Cytokine-induced killer cells
    Other Intervention Name(s)
    CIK
    Intervention Description
    The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.
    Primary Outcome Measure Information:
    Title
    Recurrence-free survival
    Description
    Recurrence-free survival (RFS) was defined as the time from the date of RFA to the date of recurrence or the date of the last follow-up.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Adverse events
    Description
    Adverse events related to RFA and CIK treatments.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients diagnosed with FIGO stage II ovarian carcinoma; cytoreductive surgery performed and 6 courses of platinum-based chemotherapy completed; medical records maintain comprehensive data on treatment and follow-up; no history of previous malignancies. Exclusion Criteria: neoadjuvant chemotherapy applied; less than 6 courses of chemotherapy or more than 6 courses of chemotherapy completed; medical records maintain incomplete data on treatment or follow-up; history of previous malignancy.

    12. IPD Sharing Statement

    Learn more about this trial

    Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Ovarian Carcinoma

    We'll reach out to this number within 24 hrs