Safety study of AFP post TACE

JRCT ID: jRCTs041180155

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: hepatocellular carcinoma
• Date of first enrollment: 17/10/2017
• Target sample size: 8
• Study type: Interventional
• Intervention(s): Subcutaneous administration of AFP-derived peptide

Outcome(s)

• Primary Outcome: Severe adverse events
• Secondary Outcome: Time to progression, Overall survival, Immune response, Complete rate, Adverse events

Key inclusion & exclusion criteria

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

Include criteria

1) Clinically diagnosed as hepatocellular carcinoma
2) Conducted transarterial chemoembolization
3) Complete response to transarterial chemoembolization
4) Recovery from adverse events for transarterial chemoembolization
5) HLA A24
6) Child Pugh classification A or B
7) 20 years or older
8) ECOG Performance status 0, 1 or 2
9) Reserved major organ function
Neutrophil 1,000/mm3 or more; Hemoglobin 8.0 g/dl or more; Platelet 40,000 /mm3 or more; Total bilirubin 3.0 mg/dl or less
10) Written informed consent

Exclude criteria

1) Refractory ascites or pleural effusion
2) History of hepatic encephalopathy within 3 months
3) Risky varices
4) Active double cancer
5) Transfusion of RCC, PC, FFP, or G-CSF within 2 weeks
6) Administration of steroid or immuno suppressive agents
7) Severe complication
8) Systemic infection (excluded viral hepatitis)
9) Pregnant or lactating women, or women of childbearing potential
10) Mental disorder
11) Allergy for AFP derived peptides or adjuvant
12) Allergy for contrast agent of CT or/and MRI
13) Inappropriate candidate for this study judged by doctor in charge

Related Information

• Primary Sponsor: Mizukoshi Eishiro
• Secondary ID(s): UMIN000029412