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临床试验/KCT0004533
KCT0004533已完成未知

Durvalumab(MEDI4736)/tremelimumab plus paclitaxel in patients with hypermutated gastric cancer who fail a first-line chemotherapy.

Asan Medical Center0 个研究点目标入组 48 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
未知
状态
已完成
入组人数
48
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

The combination chemotherapy of durvalumab, tremelimumab, and paclitaxel showed encouraging efficacy, especially in mGC with TMB >20/Mb or MSI-high mGC, as a second-line chemotherapy with manageable toxicities in biomarker-selected mGC.

研究设计

研究类型
Interventional Study

入排标准

年龄范围
19(Year) 至 o Limit（—）
性别
All

入选标准

  • •1.Have histologically- or cytologically- confirmed diagnosis of metastatic gastric carcinoma.
  • •2.Have a performance status of 0-1 on the ECOG Performance Scale.
  • •3.(for the phase II section) Have either CD274 amplification or a hypermutation or EBV positive
  • •4.(for the phase II section) Have at least one investigator-assessed measurable disease per RECIST v1.1
  • •5.Have failed a first-line fluoropyrimidine/platinum-containing chemotherapy for metastatic disease.
  • •6.Have adequate organ functions

排除标准

  • •1.Prior immunotherapy, vaccine trial, or taxane therapy for gastric cancer
  • •2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs, except for dexamethasone used for paclitaxel premedication
  • •3.Uncontrolled CNS metastasis

研究者

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Durvalumab(MEDI4736)/tremelimumab plus paclitaxel in... | 临床试验