Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy

Not Applicable

Completed

• Conditions: Primary Hepatocellular Carcinoma
• Interventions: Biological: DC-TC+GM-CSF

• Registration Number: NCT01828762
• Lead Sponsor: Shanghai AbelZeta Ltd.

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.

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 Timeline

• Study Start: 2012-12
• Status Verified: 2013-04
• Study First Submitted: 2013-04-02
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-11
• Primary Completion: 2013-12
• Last Update Submitted: 2013-12-20
• Last Update Posted: 2013-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DC-TC+GM-CSF	DC-TC+GM-CSF	-

Primary Outcome Measures

Name	Time	Method
Vital signs，physical examinations and adverse events	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.

Trial Locations

Locations (1)

9585 Humin Road,Xuhui district; 🇨🇳 Shanghai, Shanghai, China