A Phase II study of Glypican-3(GPC3) peptide vaccine as adjuvant treatment for Hepatocellular carcinoma(HCC) after Surgical resection or Radiofrequency ablation(RFA)

A Phase II study of Glypican-3(GPC3) peptide vaccine as adjuvant treatment for Hepatocellular carcinoma(HCC) after Surgical resection or Radiofrequency ablation(RFA) - A Phase II study of GPC3 peptide vaccine as adjuvant treatment in the prevention of recurrence of HCC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002614

Enrollment

Registered

2009-10-11

Start date

2009-10-01

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

Hepatocellular carcinoma(HCC)

Interventions

Injection of HLA-A24- or -A2-restricted GPC3 peptide (EYILSLEEL or FVGEFFTDV) Emulsified with Montanide ISA51 adjuvant. 3 mg intradermally injection, every 2 weeks, 6 times, and every 2 months, 4 t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosed as initial HCC 2. Subjects who undergone potentially curative surgical resection or RFA for treatment of HCC 3. 4 to 6 weeks from resection or RFA, to CT/MRI scan date. Confirmation of CR (absence of residual tumor after curative treatment), on the eligibility CT/MRI scan. 4. Age: 20-85 years old 5. ECOG performance status of 0-2 6. Child-Pugh A or B 7. Meet the following criteria for organ functions. Serum bilirubin:less than 3.0 mg/dL Serum AST/ALT:less than 200U/L Serum creatinine:less than 1.5 mg/dL 8. Written informed consent has been obtained. 9. HLA-A24 or -A2 positive

Exclusion criteria

Exclusion criteria: 1. Evident invasion to the portal vein, hepatic vein, or bile duct 2. Uncontrolled pleural effusion or ascites 3. There are other malignancies 4. Active infection excluding HBV, HCV 5. Clinically significant heart disease (myocardial infarction or unstable angina within the past six months, or uncontrolled cardiac arrhythmias) 6. There are severe complications including cardiac failure, renal failure, liver failure, active gastro-duodenal ulcer, ileus, and uncontrolled Diabetes Mellitus 7. There is severe psychiatric disorder 8. Pregnant or lactating woman, who are willing to be pregnant 9. Past history of severe drug allergy 10. Responsible doctors judged the patient in appropriate for the trial

Design outcomes

Primary

Measure	Time frame
The one-year and two-year recurrence rate	—

Secondary

Measure	Time frame
Adverse effects of GPC3 vaccination. GPC3-specific immune-responses to GPC3 vaccination.	—

Countries

Japan

Contacts

Public ContactTetsuya Nakatsura

Research Center for Innovative Oncology, National Cancer Center Hospital East Division of Cancer Immunotherapy,

tnakatsu@east.ncc.go.jp04-7131-5490

Outcome results

None listed

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