Phase II clinical trial of personalized peptide vaccination for standard therapy failed liver cancer patients. (except HCV positive patients in stage IV)

Phase II clinical trial of personalized peptide vaccination for standard therapy failed liver cancer patients. (except HCV positive patients in stage IV) - Randomized Phase II study of peptide vaccination for liver cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003590

Enrollment

100

Registered

2010-05-10

Start date

2010-05-08

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

(1st treatment: total 6 times, every weeks) Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides that showed the highest

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must satisfy the following conditions. 1) Patients must be diagnosed as standard therapy failed liver cancer.except HCV positive patients in stage IV) 2) Patients must be at a score level 0~1 of performance status (PS) (ECOG). 3) Patients must have IgG reactive to at least two of candidate peptides. 4)Patients must be expected to survive more than 3 months. 6) Patients must satisfy the followings: WBC is more than 2,500/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 6) Patients must be more 20 year-old. 7) Written informed consent must be obtained from patients. 8) Patients must be positive for HLA-A2,HLA-A24, HLA-A26, or HLA-A3 super type.

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 the past history of severe allergic reactions. 3) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination. 4) Patients who are judged inappropriate for the clinical trial by doctors.

Design outcomes

Primary

Measure	Time frame
Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination.	—

Secondary

Measure	Time frame
1. Evaluation of long-term prognosis (progression free survival and total survival). 2. Adverse effects of peptide vaccination with estramustine / safety of the protocol is evaluated based on the NCI-CTC.	—

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