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Clinical Study of the Safety of Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy

18 Years
80 Years
Open (Enrolling)
Primary Hepatocellular Carcinoma

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Trial Information

Clinical Study of the Safety of Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy

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.

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Vital signs´╝îphysical examinations and adverse events

Outcome 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.

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Chengwei Chen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shanghai 85 Hospital


China: Ministry of Health

Study ID:




Start Date:

December 2012

Completion Date:

Related Keywords:

  • Primary Hepatocellular Carcinoma
  • DC
  • Immunotherapy
  • TC
  • Carcinoma
  • Carcinoma, Hepatocellular