JPRN-jRCTc031210185已完成1 期
A clinical trial on the safety of combination therapy with dendritic cell vaccine pulsed with neoantigen peptides and immune check point inhibitor for malignant tumor.
Takimoto Rishu0 个研究点目标入组 3 人开始时间: 2021年7月6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
- 3
研究概览
简要总结
The study is terminated due to lack of hope for case enrollment.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable(—)
- 性别
- All
入选标准
- •(1)Be diagnosed with malignant tumor by imaging findings or pathological or cytological study.
- •(2)Have a successful genetic analysis of tumor sample at Seta Clinic Tokyo or production of neoantigen DCs at Seta Clinic Tokyo.
- •(3)Have an Eastern Cooperative Oncology Group performance-status score of 0 or 1.
- •(4)Visit outpatient department on schedule.
- •(5)Have an adequate function of liver, kidney, and bone marrow when the eligibility is confirmed.
- •(6) Provide agreement of the attending doctor to participate in this study.
- •(7) Have a backup hospital in the case of emergency.
- •(8)Provide written consent to participate this study.
排除标准
- •(1)Be apparent from the clinical manifestation of pulmonary fibrosis or interstitial pneumonia.
- •(2)Have a history of a serious drug allergy.
- •(3)Have a positive result of HIV antibody.
- •(4)Have a serious cardiac disorder.
- •(5)Have an active autoimmune disorder.
- •(6)Have a concurrent cancer.
- •(7)Have an infectious disorder that is difficult to control.
- •(8)Be a female who is pregnant, lactating, or with a possibility of pregnancy.
- •(9)A patient who is judged as inadequate for enrolment by doctors is excluded
研究者
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