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

Phase 1

• Conditions: Hepatocellular carcinoma

• Registration Number: JPRN-UMIN000001395
• Lead Sponsor: Section for Cancer Immunotherapy, Investigative Treatment Division, Research Center for Innovative Oncology, National Cancer Center Hospital East

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-26
• Study Completion: 2009-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified