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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Primary Hepatocellular Carcinoma Biological: DC-TC+GM-CSF Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of the Safety of Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy
Study Start Date : December 2012
Actual Primary Completion Date : December 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: DC-TC+GM-CSF Biological: DC-TC+GM-CSF


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828762


Locations
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China, Shanghai
9585 Humin Road,Xuhui district
Shanghai, Shanghai, China, 200235
Sponsors and Collaborators
Cellular Biomedicine Group Ltd.
No.85 Hospital, Changning, Shanghai, China
China Cell Technology Ltd.
Investigators
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Principal Investigator: Chengwei Chen No.85 Hospital, Changning, Shanghai, China
More Information
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Responsible Party: Cellular Biomedicine Group Ltd.
ClinicalTrials.gov Identifier: NCT01828762    
Other Study ID Numbers: 040420100005
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: December 23, 2013
Last Verified: April 2013
Keywords provided by Cellular Biomedicine Group Ltd.:
DC
Immunotherapy
TC
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases