JPRN-jRCTc040190093招募中1 期
Safety study of adjuvant therapy using peptides pulsed dendritic cell vaccine after radiofrequency ablation for hepatocellular carcinoma - RFA peptide DC
Mizukoshi Eishiro0 个研究点目标入组 6 人开始时间: 2019年12月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Other
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) The patient was clinically diagnosed with hepatocellular carcinoma (on histology or imaging).
- •2) It was judged to be the adaptation of percutaneous local treatment, and RFA was carried out.
- •3) It has been confirmed that the good cauterization necrosis was obtained in the node which was made to be the treatment object of RFA.
- •4) Adverse events (Pyrexia, pain, etc.) due to RFA have not disappeared or worsened.
- •5) Patients with HLA (Human Leukocyte Antigen) -A24 positive human tumor histocompatibility antigen.
- •6) Child-Pugh classification is A or B.
- •7) Age at entry (full age) is 20 years or older.
- •8) The ECOG Performance status is not more than 1 (0-1).
- •9) The most recent test result within 14 days before registration satisfies all of the following.
- •WBC > 2,000/mm3
- •Hemoglobin > 8.5 g/dl
- •Platelet count > 50,000/mm3
- •Serum creatinine < 1.5 mg/dl
- •10) The patient has given written consent to the study.
排除标准
- •1) Untreatable ascites and moderate or severe pleural effusion were confirmed.
- •2) The patient had a history of hepatic encephalopathy within 3 months before registration.
- •3) Esophagogastric varices at risk of bleeding have been identified, and no preventive measures have been taken.
- •4) The patient has an active malignant tumor.
- •5) Blood transfusions, blood products (Contain a preparation of albumin), and blood enhancing factor products such as G-CSF were administered within 2 weeks before enrollment.
- •6) The patient received continuous systemic administration of steroids or other immunosuppressants (Oral or intravenous administration).
- •7) The patient had serious complications (Cardiac failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction, poorly controlled diabetes mellitus, etc.).
- •8) If you are a patient with infection (except for viral hepatitis) requiring systemic treatment.
- •9) Women who are pregnant, possibly pregnant, within 28 days after childbirth, or breastfeeding. A man who wishes to conceive his partner.
- •10) It is judged that participation in the test is difficult because mental disease or mental manifestation is combined.
- •11) The patient has serious hypersensitivity to components of peptide-stimulated dendritic cells.
- •12) Neither CT nor MRI with contrast agent can be performed due to drug allergy.
- •13) In addition, the attending physician determines that participation in this study is inappropriate.
研究者
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