Back to resultsRadiofrquency Ablation Combined With Cytokine-induced Killer Cells for Colorectal Cancer Liver Metastases
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Radiofrequency ablation
Cytokine-induced killer cells
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring radiofrequency ablation, cytokine-induced killer cells, colorectal cancer iver metastases
Eligibility Criteria
Inclusion Criteria:
- Patients with histologically confirmed adenocarcinoma
- Primary lesions (colorectal cancer) are resected
- Must have undergone prior complete resection of the primary tumor; liver metastases
- Must be resectable or accessible for radiofrequency ablation (Five or less lung metastases measuring 5 cm or smaller).
- Serum bilirubin level of 2.0 mg/dl or less.
- Performance status of 0 or 1.
- Expected survival of 1 year or more.
- Informed consent from the patient.
Exclusion Criteria:
- With extrahepatic metastases
- With other neoplastic disease that is measurable or being treated other than colorectal cancer.
Sites / Locations
- The First People's Hospital of Changzhou
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
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.
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
NCT ID
NCT02419677
First Posted
April 9, 2015
Last Updated
April 14, 2015
Sponsor
The First People's Hospital of Changzhou
1. Study Identification
Unique Protocol Identification Number
NCT02419677
Brief Title
Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for Colorectal Cancer Liver Metastases
Official Title
Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for Colorectal Cancer Liver Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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 determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with colorectal cancer liver metastases (CRCLM).
Detailed Description
The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with resectable CRCLM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
radiofrequency ablation, cytokine-induced killer cells, colorectal cancer iver metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RFA alone
Arm Type
Other
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.
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
One year
Secondary Outcome Measure Information:
Title
Adverse events
Description
Adverse events related to RFA and CIK treatments.
Time Frame
4 weeks
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 with histologically confirmed adenocarcinoma
Primary lesions (colorectal cancer) are resected
Must have undergone prior complete resection of the primary tumor; liver metastases
Must be resectable or accessible for radiofrequency ablation (Five or less lung metastases measuring 5 cm or smaller).
Serum bilirubin level of 2.0 mg/dl or less.
Performance status of 0 or 1.
Expected survival of 1 year or more.
Informed consent from the patient.
Exclusion Criteria:
With extrahepatic metastases
With other neoplastic disease that is measurable or being treated other than colorectal cancer.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changping Wu, M.D.
Organizational Affiliation
The First People's Hospital of Changzhou
Official's Role
Study Director
Facility Information:
Facility Name
The First People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
12. IPD Sharing Statement
Learn more about this trial
Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for Colorectal Cancer Liver Metastases
We'll reach out to this number within 24 hrs