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疗战略。最近对肿瘤中驱动增殖或促进生存的分子异常的了解取得了进展，这导致了许多针对这些异常的治疗药物的发展。研究将筛选分子特征，以预测对具有特定作用机制的靶向药物的反应。在某些情况下，研究设计将使用“伞形方案”，即分子筛选的单一入口点将患者分配到多个单臂2/3期试验中。该系列试验的一个例子是MATCH，该试验于2015年7月开放患者登记。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，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.