Antiangiogenic Peptide Vaccine Therapy in Treating Patient With Hepatocellular Carcinoma

Phase 1 Study of HLA-A*2402 Restricted Antiangiogenic Peptide Vaccine Therapy Using Epitope Peptide Derived Feom VEGFR1 and VEGFR2 in Treating Patients With Unresectable, Recurrent, or Metastatic Hepatocellular Carcinoma

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01266707

Enrollment

Registered

2010-12-24

Start date

2007-03-31

Completion date

2013-03-31

Last updated

2010-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma, peptide vaccine, VEGFR

Brief summary

The purpose of this study is to assess toxicities of angiogenic peptide vaccine therapy in treating HLA-A\*2402 restricted patients with advanced hepatocellular carcinoma.

Detailed description

It has been required to develop new treatment modalities for patients with advanced heptatocellular carcinoma. Immunotherapy is one of the encouraging modalities for patients. We have to assess its toxicities, clinical response and immune responsiveness.

Interventions

BIOLOGICALantiangiogenic paptide vaccine

for drugs include administration time frame

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Unresectable or treatment-resistant patients with Hepatocellular carcinoma * Measurable disease by CT scan * ECOG performance status 0-2 * Life expectancy \> 3 months * Laboratory values as follows: 2,000/mm3 \< WBC \<15,000/mm3, Platelet counts \> 75,000/mm3, Total Bilirubin \< 1.5 mg/dl, Asparate transaminase \< 150IU/L, Alanine transaminase \< 150 IU/L, Creatinine \< 3.0mg/dl * HLA-A\*2402 * Able and willing to give valid written informed consent

Exclusion criteria

* Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) * Brest-feeder * Active or uncontrolled infection * Steroids or immunosuppressing agent dependent status * Active or uncontrolled other malignancy * Serious or uncured wound * Decision of unsuitableness by principal investigator or physician-in charge

Design outcomes

Primary

Measure	Time frame
Toxicities as assessed by NCI-CACAE ver3	3 months

Secondary

Measure	Time frame
CD8 population	3 months
Change in level of regulatory T cells	3 months
Differences of peptide specific CTL response in vitro among sequence of peptide vaccine administration	3 months
Feasibility	1 year
Survival	1 year
Objective response rate	1 year

Countries

Japan

Contacts

Primary ContactAkira Kenjo, MD

a-kenjo@fmu.ac.jp+81-24-547-1111

Backup ContactTakashi Kimura, MD, PhD

tkimura@fmu.ac.jp+81-24-547-1111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026