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

NCT01828762 | Completed DMC

• 1 other identifier: 040420100005
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Hepatocellular Carcinoma

Keywords

DC; Immunotherapy; TC

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

DC-TC+GM-CSF

EXPERIMENTAL

Biological: DC-TC+GM-CSF

Interventions

DC-TC+GM-CSF BIOLOGICAL

DC-TC+GM-CSF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai AbelZeta Ltd.: lead
• No.85 Hospital, Changning, Shanghai, China: collaborator
• China Cell Technology Ltd.: collaborator

Study Sites (1)

9585 Humin Road,Xuhui district

Shanghai, Shanghai Municipality, 200235, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Chengwei Chen

  No.85 Hospital, Changning, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 11, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Last Updated: December 23, 2013

Record last verified: 2013-04

Locations

CN (1)