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临床试验/JPRN-jRCTc030190263
JPRN-jRCTc030190263招募中1 期

A clinical study on the safety of comprehensive therapy against hepatocarcinoma: combination of TAE and RFA, dendric cell.

Shiina Shuichiro0 个研究点目标入组 3 人开始时间: 2020年3月23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
3

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)Patients must weigh over 50 kg.
  • (8)Liver damage or Child-pugh classificaion must be A or B according to latest clinical guideline for primary hepatocellular carcinoma.
  • (9)Bone marrow and kidney function should be adequate at qualification confirmation.
  • (10)Written consent should be obtained for participation to this study.
  • (11)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

发起方
Shiina Shuichiro

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