AFP peptides after TACE

JRCT ID: jRCT2041220154

Registered date:02/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 29/03/2023
• Target sample size: 84
• Study type: Interventional
• Intervention(s): Six courses of subcutaneous administration of AFP derived peptides (AFP 357 3mg and AFP 403 3mg) or placebo every two weeks.

Outcome(s)

• Primary Outcome: Relapse-free survival
• Secondary Outcome: Immunological response, Adverse events, Overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Mizukoshi Eishiro