MOLECULAR ANALYSIS OF TUMORS FOR TREATMENT SELECTION IN CLINICAL TRIALS- PHASE II

美国国家癌症研究所（NCI）正在继续追求临床试验概念，将基因组学纳入不断发展的国家精准医学战略。在肿瘤中驱动增殖或促进存活的分子异常的知识方面的最新进展已经导致了许多靶向这些异常的治疗剂的开发。研究将筛选可能预测对具有特定作用机制的靶向药物反应的分子特征。在某些情况下，研究设计将使用“伞形方案”，即分子筛选的单一进入点将患者分配到多个单臂2/3期试验。该系列试验的一个例子MATCH于2015年7月开放供患者入组。其他试验将使用富集设计，其中特定的分子特征是合格标准，并且治疗仅限于此类患者。

The National Cancer Institute (NCI) is continuing to pursue clinical trials concepts that incorporate genomics into the evolving national strategy for precision medicine. Recent advances in knowledge of the molecular abnormalities in tumors that either drive proliferation or promote survival have led to the development of many therapeutic agents that target those abnormalities. Studies will screen for molecular features that may predict response to a targeted agent with a specific mechanism of action. In some cases, the study designs will use an "umbrella protocol" whereby a single entry point for molecular screening will then distribute patients to multiple, single-arm phase 2/3 trials. One example of the trials in the series, MATCH, was open for patient enrollment in July 2015. Other trials will use enrichment designs where the particular molecular characteristic is an eligibility criterion and the therapy is limited to such patients.