Back to resultsA Study of DC-CIK to Treat Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma (HCC)
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Dendritic and Cytokine-induced Killer Cells
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma (HCC) focused on measuring Hepatocellular carcinoma, DC-CIK
Eligibility Criteria
Inclusion Criteria:
- Male or female patients > 18 years of age;
- Hepatocellular carcinoma with histological or imaging and AFP diagnose, and had received complete resection or TACE and got CR or PR by imaging studies;
- 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 > 4.0×109/L, Hb > 120 g/L, PLT > 100×109/L);
- The ECG results were normal, and the liver and kidney were functional.
Exclusion Criteria:
- Patients who had distant metastases;
- Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
- Patients who were pregnant or lactating;
- ECOG perform status ≥ 2;
- Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.
Sites / Locations
- The first Affiliated Hospital of Guangxi Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A
B
Arm Description
After complete resection or TACE, patients will receive 3 cycles of Dendritic and Cytokine-induced Killer Cells (DC-CIK) (every 4 weeks)
After complete resection or TACE, Patient only regularly follow up
Outcomes
Primary Outcome Measures
progression-free survival(PFS)
Secondary Outcome Measures
Overall survival(OS)
quality of life (QOL)
Full Information
NCT ID
NCT01821482
First Posted
March 27, 2013
Last Updated
April 11, 2013
Sponsor
Guangxi Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01821482
Brief Title
A Study of DC-CIK to Treat Hepatocellular Carcinoma
Official Title
A Randomized Controlled Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangxi Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of Dendritic and Cytokine-induced Killer Cells (DC-CIK) for hepatocellular carcinoma (HCC).
Detailed Description
About 60 patients with HCC, who had received complete resection or TACE and got Complete remission (CR) or partial response (PR), will be randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of DC-CIK cells treatment (every 4 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
Hepatocellular Carcinoma (HCC)
Keywords
Hepatocellular carcinoma, DC-CIK
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
After complete resection or TACE, patients will receive 3 cycles of Dendritic and Cytokine-induced Killer Cells (DC-CIK) (every 4 weeks)
Arm Title
B
Arm Type
No Intervention
Arm Description
After complete resection or TACE, Patient only regularly follow up
Intervention Type
Biological
Intervention Name(s)
Dendritic and Cytokine-induced Killer Cells
Other Intervention Name(s)
DC-CIK
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
Title
quality of life (QOL)
Time Frame
month
Other Pre-specified Outcome Measures:
Title
Laboratory findings
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients > 18 years of age;
Hepatocellular carcinoma with histological or imaging and AFP diagnose, and had received complete resection or TACE and got CR or PR by imaging studies;
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 > 4.0×109/L, Hb > 120 g/L, PLT > 100×109/L);
The ECG results were normal, and the liver and kidney were functional.
Exclusion Criteria:
Patients who had distant metastases;
Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
Patients who were pregnant or lactating;
ECOG perform status ≥ 2;
Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanfeng Liu
Phone
86-771-3277289
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanfeng Liu
Organizational Affiliation
Guangxi Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The first Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanfeng Liu
Phone
86-771-3277289
First Name & Middle Initial & Last Name & Degree
Hanfeng Liu
12. IPD Sharing Statement
Learn more about this trial
A Study of DC-CIK to Treat Hepatocellular Carcinoma
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