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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


Phase 1
20 Years
80 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicities as assessed by NCI-CACAE ver3

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Mitsukazu Gotoh, PhD & MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fukushima Medical University, Department of Regeneration Surgery

Authority:

Japan: Institutional Review Board

Study ID:

560

NCT ID:

NCT01266707

Start Date:

March 2007

Completion Date:

March 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular carcinoma
  • peptide vaccine
  • VEGFR
  • Carcinoma
  • Carcinoma, Hepatocellular

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