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

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ClinicalTrials.gov Identifier: NCT01828762
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : December 23, 2013
Sponsor:
Collaborators:
No.85 Hospital, Changning, Shanghai, China
China Cell Technology Ltd.
Information provided by (Responsible Party):
Cellular Biomedicine Group Ltd.

Tracking Information
First Submitted Date  ICMJE April 2, 2013
First Posted Date  ICMJE April 11, 2013
Last Update Posted Date December 23, 2013
Study Start Date  ICMJE December 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy
Official Title  ICMJE Clinical Study of the Safety of Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Hepatocellular Carcinoma
Intervention  ICMJE Biological: DC-TC+GM-CSF
Study Arms  ICMJE Experimental: DC-TC+GM-CSF
Intervention: Biological: DC-TC+GM-CSF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2013)
8
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01828762
Other Study ID Numbers  ICMJE 040420100005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cellular Biomedicine Group Ltd.
Study Sponsor  ICMJE Cellular Biomedicine Group Ltd.
Collaborators  ICMJE
  • No.85 Hospital, Changning, Shanghai, China
  • China Cell Technology Ltd.
Investigators  ICMJE
Principal Investigator: Chengwei Chen No.85 Hospital, Changning, Shanghai, China
PRS Account Cellular Biomedicine Group Ltd.
Verification Date April 2013

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