Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cervical Cancer
Primary Purpose
Cervical Cancer
Status
Active
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Radiofrequency ablation
Cytokine-induced killer cells
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer
Eligibility Criteria
Inclusion Criteria:
- They were systematic reviews based on randomized controlled trials (rcts). They were phase II rcts comparing chemotherapy with other systemic therapy agents or with no further treatment for recurrent, metastatic, or persistent cervical cancer.
they reported at least one of these outcomes: complete or partial response rate, overall or progression-free survival rate, adverse effects, or healthrelated quality of life (rcts reporting on heterogeneous populations-for example, women at a range of disease stages-were included if results were given separately for patients with recurrent, metastatic, or persistent cervical cancer).
Exclusion Criteria:
- studies evaluating the role of radiotherapy administered with chemotherapy, or second- or subsequent-line therapy options.
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
Full Information
NCT ID
NCT02490748
First Posted
July 2, 2015
Last Updated
February 21, 2016
Sponsor
The First People's Hospital of Changzhou
1. Study Identification
Unique Protocol Identification Number
NCT02490748
Brief Title
Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cervical Cancer
Official Title
Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cervical 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
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 cervical cancer.
Detailed Description
The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with cervical cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
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
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:
They were systematic reviews based on randomized controlled trials (rcts). They were phase II rcts comparing chemotherapy with other systemic therapy agents or with no further treatment for recurrent, metastatic, or persistent cervical cancer.
they reported at least one of these outcomes: complete or partial response rate, overall or progression-free survival rate, adverse effects, or healthrelated quality of life (rcts reporting on heterogeneous populations-for example, women at a range of disease stages-were included if results were given separately for patients with recurrent, metastatic, or persistent cervical cancer).
Exclusion Criteria:
studies evaluating the role of radiotherapy administered with chemotherapy, or second- or subsequent-line therapy options.
12. IPD Sharing Statement
Learn more about this trial
Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cervical Cancer
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