NCT00327496

Brief Summary

Hepatoma ranks the first on the cancer mortality list in Taiwan, and there are currently no other effective treatment options for advanced HCC. Therefore, alternative medical intervention is needed to improve the survival and quality of life of these patients. Dendritic cells are the most potent type of antigen presenting cells in the human body, and are involved in the regulation of both innate and adoptive immune responses. If we use matured antigen presenting cells pulsed in vitro with appropriate tumor associated antigens under optimal activation conditions. It is anticipated that such treatment might generate or reactivate a cytotoxic T lymphocyte response against tumor cells and thereby inhibit tumor growth. Although there are excited results of tumor vaccine in animal models but successful clinical tries are rare. There are still some problems needed to be resolved such as immune deficiency of the cancer patients or the defect of T cell receptors or the problems of tumor escape. There are complex compositions in tumor cells to be a tumor antigen that will influence the efficacy of tumor vaccine, so we are going to use tumor lysate to be a tumor antigen. In this study, the generation of dendritic cells from the patient's peripheral blood will use rhGM-CSF and rhIL-4 as stimulating factors, and matured dendritic cells will pulse with tumor lysate, the ex vivo T cell cytotoxicity for the primary tumor cell will be test. We hope to cooperate with basic study group in our hospital to do more ex vivo tests and clinical trials in the future.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2005

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2006

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

May 18, 2006

Status Verified

June 1, 2005

First QC Date

May 16, 2006

Last Update Submit

May 16, 2006

Conditions

Interventions

DC vaccineBIOLOGICAL

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hepatoma patients indicated for operation

You may not qualify if:

  • With major systemic disease including other cancer or coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lentiviral minigene vaccine of COVID-19 coronavirus

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Ching-Chung Lin, MD

    Division of Gastroenterology, Mackay Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2006

First Posted

May 18, 2006

Study Start

June 1, 2005

Study Completion

June 1, 2006

Last Updated

May 18, 2006

Record last verified: 2005-06