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

Primary Hepatocellular Carcinoma Clinical Trial

— DC-TC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828762
• Other study ID #: 040420100005
• Status: Completed
• Phase: N/A
• First received: April 2, 2013
• Last updated: December 20, 2013
• Start date: December 2012

Study information

• Verified date: April 2013
• Source: Cellular Biomedicine Group Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Primary Hepatocellular Carcinoma

Intervention

Biological:
• DC-TC+GM-CSF

Locations

Country	Name	City	State
China	9585 Humin Road,Xuhui district	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Cellular Biomedicine Group Ltd.	China Cell Technology Ltd. licensed CBMG to conduct the clinical trial as the sponsor in China, No.85 Hospital, Changning, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital signs,physical examinations and adverse events	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.	one year	Yes