Phase I study of peptide-cocktail vaccination for HCV-positive patients with liver cancer who have undergone radical therapy.

Phase I study of peptide-cocktail vaccination for HCV-positive patients with liver cancer who have undergone radical therapy. - Peptid vaccination to prevent recurrence of HCV-positive liver cancer.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003773

Enrollment

Registered

2010-06-21

Start date

2010-06-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

liver cancer

Interventions

&lt

Treatment with 6 times, every weeks&gt

Interview : Day1, 8, 15, 22, 29, 36 Treatment : Day1, 8, 15, 22, 29, 36 Watching adverse events : Day1, 8, 15, 22, 29, 36 Immune function test : Day36 Blood test : Day36

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must satisfy the following conditions. 1)HCV-positive patients with liver cancer who have undergone radical therapy and no legion has been confirmed by ultrasonography and/or CT. 2) Patients must be at a score level 0~1 of performance status (PS) (ECOG). 3) Patients must satisfy the followings: WBC is more than 2,200/mm3 Lymphocyte is more than 1,000/mm3 Hb is more than 8.0g/dL Platelet is more than 50,000/mm3 Serum Creatinine is less than 2.0mg/dL Total Bilirubin is less than 2.5mg/dL 4) Patients must be at a total score level 7 or less of Child-Pugh 5) Patients must be more 20 year-old or more to 80 years old or less. 6)Patients must be expected to survive more than 3 months. 7) Written informed consent must be obtained from patients.

Exclusion criteria

Exclusion criteria: The following patients must be excluded: 1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 2)Patients with multiple active cancers 3)Patients suspected with immunodeficiency and opportunistic infection. 4) Patients with the past history of severe allergic reactions. 5)Patients who are during pregnancy, lactation expectant, and desiring future fertility. 6)Patients with a score II or more of hepatic encephalopathy. 7) Patients who are judged inappropriate for the clinical trial by doctors.

Design outcomes

Primary

Measure	Time frame
Safety, to evaluate with CTCAE v4.0	—

Secondary

Measure	Time frame
Immunological responses (anti-peptide IgG)	—

Countries

Japan

Contacts

Public ContactAkira Yamada

Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division

akiymd@med.kurume-u.ac.jp0942-31-7572

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026