Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy (DC-TC)
Primary Purpose
Primary Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DC-TC+GM-CSF
Sponsored by

About this trial
This is an interventional treatment trial for Primary Hepatocellular Carcinoma focused on measuring DC, Immunotherapy, TC
Eligibility Criteria
Inclusion Criteria:
- Voluntary written informed consent signed by patient or legal guardian, obtained prior to study enrollment.
- BCLC Classification A-B
- Patients who are good surgical candidates for HCC resection
- ECOG Performance Score, 0-1
- Child-Pugh Rating, A
- Expected survival greater than 6 months
Exclusion Criteria:
- History of anaphylactic reaction to GM-CSF
- Congestive heart failure, unstable angina or other underlying cardiac disease; history of thrombosis currently requiring anticoagulation
- Mental or psychological illness preventing cooperation with treatment, efficacy evaluations, or unable to understand the informed consent process
- Primary cancers of any kind or location, other than hepatocellular carcinoma
- Excluding hepatitis, any active or unresolved infection including HIV, EBV, CMV, RPR, TB, etc.
- Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy.
- Prior clinical trial requiring patient to receive an investigational drug within two weeks of enrollment.
- Pregnant or lactating women.
- Patients with the intention to receive transplantation
- Significant comorbidity or other active medical condition that could be eminently life threatening in the opinion of the investigator, including no active blood clotting or bleeding diathesis.
- Evidence of metastatic disease.
Sites / Locations
- 9585 Humin Road,Xuhui district
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DC-TC+GM-CSF
Arm Description
Outcomes
Primary Outcome Measures
Vital signs,physical examinations and adverse events
The number of adverse events along with the results of vital signs measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of DC-TC.
Secondary Outcome Measures
Full Information
NCT ID
NCT01828762
First Posted
April 2, 2013
Last Updated
December 20, 2013
Sponsor
Cellular Biomedicine Group Ltd.
Collaborators
No.85 Hospital, Changning, Shanghai, China, China Cell Technology Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01828762
Brief Title
Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy
Acronym
DC-TC
Official Title
Clinical Study of the Safety of Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellular Biomedicine Group Ltd.
Collaborators
No.85 Hospital, Changning, Shanghai, China, China Cell Technology Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Although liver resection, liver transplantation, a-interferon, Transarterial Chemo Embolization (TACE), percutaneous ethanol injection (PEI), Percutaneous microwave coagulation therapy (PMCT), Radiofrequency ablation (RFA) provide options to treat patients with HCC, the high recurrence rate of mid-late stage liver cancer still exists. The safety of autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma (HCC) Patients Following Resection and TACE Therapy will be evaluated.
Detailed Description
The study is a single center,open label trial. To obtain safety information on toxicities and adverse events attributable to the subcutaneous injections of autologous dendritic cells incubated with irradiated autologous tumor stem cells and suspended in GM-CSF in patients with HCC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hepatocellular Carcinoma
Keywords
DC, Immunotherapy, TC
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DC-TC+GM-CSF
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
DC-TC+GM-CSF
Primary Outcome Measure Information:
Title
Vital signs,physical examinations and adverse events
Description
The number of adverse events along with the results of vital signs measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of DC-TC.
Time Frame
one year
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:
Voluntary written informed consent signed by patient or legal guardian, obtained prior to study enrollment.
BCLC Classification A-B
Patients who are good surgical candidates for HCC resection
ECOG Performance Score, 0-1
Child-Pugh Rating, A
Expected survival greater than 6 months
Exclusion Criteria:
History of anaphylactic reaction to GM-CSF
Congestive heart failure, unstable angina or other underlying cardiac disease; history of thrombosis currently requiring anticoagulation
Mental or psychological illness preventing cooperation with treatment, efficacy evaluations, or unable to understand the informed consent process
Primary cancers of any kind or location, other than hepatocellular carcinoma
Excluding hepatitis, any active or unresolved infection including HIV, EBV, CMV, RPR, TB, etc.
Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy.
Prior clinical trial requiring patient to receive an investigational drug within two weeks of enrollment.
Pregnant or lactating women.
Patients with the intention to receive transplantation
Significant comorbidity or other active medical condition that could be eminently life threatening in the opinion of the investigator, including no active blood clotting or bleeding diathesis.
Evidence of metastatic disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chengwei Chen
Organizational Affiliation
No.85 Hospital, Changning, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
9585 Humin Road,Xuhui district
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200235
Country
China
12. IPD Sharing Statement
Learn more about this trial
Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy
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