Hepatocellular carcinoma Hepatocellular carcinoma
Conditions
Interventions
Six courses of subcutaneous administration of AFP derived peptides (AFP 357 3mg and AFP 403 3mg) or placebo every two weeks.
Sponsors
Mizukoshi Eishiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) clinically diagnosed as hepatocellular carcinoma 2) unsuitable for local therapy and treated by TACE 3) recoverd by adverse events due to TACE 4) HLA (Human Leukocyte Antigen) -A24 5) Child-Pugh classification A or B 6) 20 years or older 7) ECOG Performance status <=2 8) preservation of major organ function 9) written informed consent
Exclusion criteria
Exclusion criteria: 1) refractory ascites or pleural effusion 2) encephalopathy within 3 months 3) risky varices 4) active double cancer 5) pregnant or lactating women, or women of childbearing potential 6) mental disorder 7) previously treated by AFP peptide or adjuvant 8) allergy for AFP peptide or adjuvant 9) previously treated by immunotherapy 10) allergy for contrast agents for CT and MRI 11) patients who investigator regards as inappropriate for candidate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological response, Adverse events, Overall survival | — |
Contacts
Public ContactTakeshi Terashima
Kanazawa University Hospital
Outcome results
None listed