Phase I clinical study of Glypican-3 peptide vaccine in patients with advanced Hepatocellular carcinoma

UMIN ID: UMIN000001395

Registered date:26/09/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 2007/02/01
• Target sample size: 33
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Injection of HLA-A24- or -A2-restricted GPC3 peptide (EYILSLEEL or FVGEFFTDV) emulsified with Montanide ISA51 adjuvant. Every 2 weeks, 3 times.

Outcome(s)

• Primary Outcome: 1)Adverse effects of GPC3 vaccination. 2)GPC3-specific immune-responses to GPC3 vaccination.
• Secondary Outcome: 1)Clinical response rate. 2)Monitoring the level of tumor markers.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1)Uncontrolled pleural effusion or ascites. 2)Metastatic disease to the brain. 3)There are other malignancies. 4)Active infection excluding HBV, HCV. 5)Positive for HIV. 6)Clinically significant heart disease. (myocardial infarction or unstable angina within the past six months, or uncontrolled cardiac arrhythmias) 7)There are severe complications including cardiac failure, renal failure, liver failure, active gastro-duodenal ulcer, ileus, and uncontrolled Diabetes Mellitus. 8)There is severe psychiatric disorder. 9)Pregnant or lactating woman, who are willing to be pregnant. 10)Past history of severe drug allergy. 11)Immunodeficiency, previous splenectomy, irradiation to the spleen. 12)Ongoing treatment with corticosteroid, or immunosuppressant drugs. 13)Previous allograft transplantation. 14)Responsible doctors judged the patient in appropriate for the trial.

Related Information

• Primary Sponsor: Section for Cancer Immunotherapy, Investigative Treatment Division, Research Center for Innovative Oncology, National Cancer Center Hospital East
• Source(s) of Monetary Support: The Ministry of Health, Labor and Welfare, Japan