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Antiangiogenic Peptide Vaccine Therapy in Treating Patient With Hepatocellular Carcinoma

F

Fukushima Medical University

Status and phase

Unknown
Phase 1

Conditions

Hepatocellular Carcinoma

Treatments

Biological: antiangiogenic paptide vaccine

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Vaccine
Experimental group
Description:
VEGRF1, VEGFR2
Treatment:
Biological: antiangiogenic paptide vaccine

Trial contacts and locations

1

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Central trial contact

Akira Kenjo, MD; Takashi Kimura, MD, PhD

Data sourced from clinicaltrials.gov

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