Safety study of AFP post TACE
- Conditions
- hepatocellular carcinoma
- Registration Number
- JPRN-jRCTs041180155
- Lead Sponsor
- Mizukoshi Eishiro
- Brief Summary
This study, which was designed to evaluate the safety of AFP-derived peptides in patients with HCC after TACE, showed that no serious adverse events were observed as the primary endpoint, and the only adverse events observed were known Grade1 injection site reactions. Although it is difficult to conclude definitively due to the small number of patients the efficacy of AFP-derived peptides can be expected and it was considered worthwhile to plan the next phase clinical trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 8
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method