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

This study has been completed.
Sponsor:
Collaborators:
Shanghai 85 Hospital
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.
ClinicalTrials.gov Identifier:
NCT01828762
First received: April 2, 2013
Last updated: December 20, 2013
Last verified: April 2013
  Purpose

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 Intervention
Primary Hepatocellular Carcinoma
Biological: DC-TC+GM-CSF

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Cellular Biomedicine Group Ltd.:

Primary Outcome Measures:
  • Vital signs,physical examinations and adverse events [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 8
Study Start Date: December 2012
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DC-TC+GM-CSF Biological: DC-TC+GM-CSF

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828762

Locations
China, Shanghai
9585 Humin Road,Xuhui district
Shanghai, Shanghai, China, 200235
Sponsors and Collaborators
Cellular Biomedicine Group Ltd.
Shanghai 85 Hospital
China Cell Technology Ltd. licensed CBMG to conduct the clinical trial as the sponsor in China
Investigators
Principal Investigator: Chengwei Chen Shanghai 85 Hospital
  More Information

No publications provided

Responsible Party: Cellular Biomedicine Group Ltd.
ClinicalTrials.gov Identifier: NCT01828762     History of Changes
Other Study ID Numbers: 040420100005
Study First Received: April 2, 2013
Last Updated: December 20, 2013
Health Authority: China: Ministry of Health

Keywords provided by Cellular Biomedicine Group Ltd.:
DC
Immunotherapy
TC

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 21, 2014