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临床试验/EUCTR2021-001181-38-NL
EUCTR2021-001181-38-NL进行中(未招募)1 期

Anti-PD-1, Capecitabine, and Oxaliplatin for the first-line treatment of dMMR esophagogastric cancer (AuspiCiOus-dMMR): a proof-of-principle study - AuspiCiOus

Academic Medical Center0 个研究点目标入组 25 人开始时间: 2021年5月26日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
25

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Male or female adult patients (> 18 years)
  • - Primaire tumor or metastasis accessible for repeat fresh histological biopsies
  • - dMMR identified by IHC of mismatch repair proteins MLH1, PMS2, MSH2, and MSH6
  • - Patients with histologically confirmed diagnosis of metastatic or irresectable HER2 negative adenocarcinoma of the stomach or oesophagus; patients with HER2 positive disease are eligble when treatment with trastuzumab is contraindicated. If histology cannot be obtained, cytology is acceptable to prove metastatic disease
  • - Patients with metastatic or irresectable adenocarcinoma of the stomach or oesophagus not pre-treated with chemotherapy or radiotherapy for irresectable or metastatic disease. Palliative radiotherapy on the primary tumor or a metastatic lesion is allowed if other untreated lesions eligble for evaluation are present
  • - Measurable disease as assessed by RECIST 1.1
  • - ECOG (WHO) performace status 0-2
  • - Patient has adequate hepatic, renal and hematological function
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 15
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • - Past or current malginancy other than entry diagnosis interfering with prognosis of metastatic esophagogastric cancer

研究者

发起方
Academic Medical Center

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