Status:
COMPLETED
Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy
Lead Sponsor:
Shanghai AbelZeta Ltd.
Collaborating Sponsors:
No.85 Hospital, Changning, Shanghai, China
China Cell Technology Ltd.
Conditions:
Primary Hepatocellular Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Although liver resection, liver transplantation, a-interferon, Transarterial Chemo Embolization (TACE), percutaneous ethanol injection (PEI), Percutaneous microwave coagulation therapy (PMCT), Radiofr...
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 ir...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- Evidence of metastatic disease.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01828762
Start Date
December 1 2012
Last Update
December 23 2013
Active Locations (1)
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1
9585 Humin Road,Xuhui district
Shanghai, Shanghai Municipality, China, 200235