JPRN-jRCTc050200107尚未招募1 期
A clinical study on the safety of therapy against hepatocarcinoma: combination of dendric cell and TAE followed by RFA.
akamoto Yasunari0 个研究点目标入组 30 人开始时间: 2021年1月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
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)Patients must be diagnosed as primary hepatocellular carcinoma pathologically or from images.
- •(2)Patients must be inoperable.
- •(3)Patients must have Karnofsky Performance Status above 70.
- •(4)Patients must have one or more tumor of maximum diameter larger than 2.5 cm. The number of tumor must not exceed 5.
- •(5)Patients who can be cured with TAE and radiofrequency ablation.
- •(6)Patient must be over 20 years old at registration.
- •(7)Liver damage or Child-pugh classificaion must be A or B according to latest clinical guideline for primary hepatocellular carcinoma.
- •(8)Bone marrow and kidney function should be adequate at qualification confirmation.
- •(9)Written consent should be obtained for participation to this study.
- •(10)Patient must be capable of outpatient visits.
排除标准
- •(1)Patients must not have heart disorder, kidney disorder, respiratory disorder, hematopathy, clotting disorder, or other serious complication.
- •(2)Patients must not be HIV positive.
- •(3)Patients must not have carcinoma nor immunodeficiency in past history.
- •(4)Patients must not have splenectomy nor splen radiation in past history.
- •(5)Patients must not have allo organ transplantation in past history.
- •(6)Patients must not subjected to continuous whole body administration of adrenal cortical steroid or antihistaminic.
- •(7)Patients must have no surgery, chemotherapy nor radiation within 4 weeks before blood collection for treatment in this study. In addition, patients are also excluded if they have not recovered enough from those therapies above.
- •(8)Female patients are excluded from the study when they are pregnant, possibly pregnant, or when they want to be pregnant or they are feeding.
- •(9)Patients must be excluded when expected to be difficult to follow-up.
- •(10)Patients must be excluded when principal investigator judge as inadequate.
研究者
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