JPRN-jRCTs041180155已完成1 期
Safety study of adjuvant therapy using alpha fetoprotein derived peptides after transarterial chemoembolization for hepatocellular carcinoma - TACE AFP
Mizukoshi Eishiro0 个研究点目标入组 8 人开始时间: 2019年3月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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