跳至主要内容
临床试验/JPRN-jRCT1051200028
JPRN-jRCT1051200028招募中2 期

Phase II trial on Programmed death-One inhibitor plus RadioThERapy in patients with Metastatic Mucosal Melanoma - PORTER-M3 trial

omura Motoo0 个研究点目标入组 20 人开始时间: 2020年6月22日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
20

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) Histologically proven mucosal melanoma
  • 2) Aged 20 years old or more
  • 3) metastatic disease
  • 4) No previous treatment for metastatic mucosal melanoma
  • 5) ECOG PS of 0 or 1
  • 6) Need for measurable lesion
  • 7) Adequate organ functions
  • 8) Written informed consent

排除标准

  • 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
  • 2) The current radiation field do not overlap the previous radiation field.
  • 3) Active infection requiring systemic therapy.
  • 4) Patients with immune suppression.
  • 5) Patients with central nerve system metastases.
  • 6) Patients with complications of autoimmune disease, histories of chronic and recurrent autoimmune disease or other diseases which require systemic steroid therapy or immune suppressor.
  • 7) Patients received live vaccines.
  • 8) Pregnancy, possible pregnancy or breastfeeding.
  • 9) Psychiatric disease.
  • 10) Patients requiring systemic steroid medication.
  • 11) Severe pulmonary fibrosis or emphysema.
  • 12) Patients whom principle/sub-investigator judged ineligible to participate in this study.

研究者

发起方
omura Motoo

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