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 :
First Posted : April 11, 2013
Last Update Posted : December 23, 2013
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
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
Primary Hepatocellular Carcinoma
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.
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Voluntary written informed consent signed by patient or legal guardian, obtained prior to study enrollment.
BCLC Classification A-B
Patients who are good surgical candidates for HCC resection
ECOG Performance Score, 0-1
Child-Pugh Rating, A
Expected survival greater than 6 months
History of anaphylactic reaction to GM-CSF
Congestive heart failure, unstable angina or other underlying cardiac disease; history of thrombosis currently requiring anticoagulation
Mental or psychological illness preventing cooperation with treatment, efficacy evaluations, or unable to understand the informed consent process
Primary cancers of any kind or location, other than hepatocellular carcinoma
Excluding hepatitis, any active or unresolved infection including HIV, EBV, CMV, RPR, TB, etc.
Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy.
Prior clinical trial requiring patient to receive an investigational drug within two weeks of enrollment.
Pregnant or lactating women.
Patients with the intention to receive transplantation
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.