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Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy (DC-TC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01828762
First Posted: April 11, 2013
Last Update Posted: December 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
No.85 Hospital, Changning, Shanghai, China
China Cell Technology Ltd. licensed CBMG to conduct the clinical trial as the sponsor in China
Information provided by (Responsible Party):
Cellular Biomedicine Group Ltd.
April 2, 2013
April 11, 2013
December 23, 2013
December 2012
December 2013   (Final data collection date for primary outcome measure)
Vital signs,physical examinations and adverse events [ Time Frame: one year ]
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.
Same as current
Complete list of historical versions of study NCT01828762 on ClinicalTrials.gov Archive Site
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Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy
Clinical Study of the Safety of Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy
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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Primary Hepatocellular Carcinoma
Biological: DC-TC+GM-CSF
Experimental: DC-TC+GM-CSF
Intervention: Biological: DC-TC+GM-CSF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
Not Provided
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Voluntary written informed consent signed by patient or legal guardian, obtained prior to study enrollment.
  2. BCLC Classification A-B
  3. Patients who are good surgical candidates for HCC resection
  4. ECOG Performance Score, 0-1
  5. Child-Pugh Rating, A
  6. Expected survival greater than 6 months

Exclusion Criteria:

  1. History of anaphylactic reaction to GM-CSF
  2. Congestive heart failure, unstable angina or other underlying cardiac disease; history of thrombosis currently requiring anticoagulation
  3. Mental or psychological illness preventing cooperation with treatment, efficacy evaluations, or unable to understand the informed consent process
  4. Primary cancers of any kind or location, other than hepatocellular carcinoma
  5. Excluding hepatitis, any active or unresolved infection including HIV, EBV, CMV, RPR, TB, etc.
  6. Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy.
  7. Prior clinical trial requiring patient to receive an investigational drug within two weeks of enrollment.
  8. Pregnant or lactating women.
  9. Patients with the intention to receive transplantation
  10. 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.
  11. Evidence of metastatic disease.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01828762
040420100005
Yes
Not Provided
Not Provided
Cellular Biomedicine Group Ltd.
Cellular Biomedicine Group Ltd.
  • No.85 Hospital, Changning, Shanghai, China
  • China Cell Technology Ltd. licensed CBMG to conduct the clinical trial as the sponsor in China
Principal Investigator: Chengwei Chen No.85 Hospital, Changning, Shanghai, China
Cellular Biomedicine Group Ltd.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP