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

NCT ID: NCT01828762

Last Updated: 2013-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Primary Hepatocellular Carcinoma

Keywords

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DC Immunotherapy TC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DC-TC+GM-CSF

Group Type EXPERIMENTAL

DC-TC+GM-CSF

Intervention Type BIOLOGICAL

Interventions

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DC-TC+GM-CSF

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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No.85 Hospital, Changning, Shanghai, China

OTHER

Sponsor Role collaborator

China Cell Technology Ltd.

OTHER

Sponsor Role collaborator

Shanghai AbelZeta Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chengwei Chen

Role: PRINCIPAL_INVESTIGATOR

No.85 Hospital, Changning, Shanghai, China

Locations

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9585 Humin Road,Xuhui district

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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040420100005

Identifier Type: -

Identifier Source: org_study_id