Autologous Immune Cell Therapy in Primary Hepatocellular Carcinoma Patients Following Resection and TACE Therapy (DC-TC)

December 20, 2013 updated by: Cellular Biomedicine Group Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200235
        • 9585 Humin Road,Xuhui district

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DC-TC+GM-CSF
Biological: DC-TC+GM-CSF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital signs，physical examinations and adverse events
Time Frame: 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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cellular Biomedicine Group Ltd.

Collaborators

No.85 Hospital, Changning, Shanghai, China
China Cell Technology Ltd.

Investigators

  • Principal Investigator: Chengwei Chen, No.85 Hospital, Changning, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (Estimate)

April 11, 2013

Study Record Updates

Last Update Posted (Estimate)

December 23, 2013

Last Update Submitted That Met QC Criteria

December 20, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 040420100005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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