Natera's New Cancer Trial to Use Signatera for Personalized Treatment
Natera's New Cancer Trial to Use Signatera for Personalized Treatment
Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA (cfDNA) and genetic testing, today announced a new gastroesophageal cancer trial, DECIPHER, that will utilize the company's personalized and tumor-informed molecular residual disease (MRD) test, Signatera, to guide patient selection and assess the rate of MRD clearance in patients being treated for gastroesophageal cancer.
全球领先的电芯DNA和基因检测公司Natera, Inc.（纳斯达克:NTRA）今天宣布推出一项新的胃食管癌临床试验DECIPHER，该试验将利用该公司的个性化和肿瘤知情的分子残留疾病（MRD）检测——Signatera，指导病人选择并评估正在接受胃食管癌治疗的病人MRD清除的速率。
DECIPHER (Developing ctDNA Guided Adjuvant Therapy for Gastroesophageal Cancer) is a single-arm, open-label phase II trial, and the first trial to evaluate the efficacy of a HER2-directed antibody-drug conjugate in gastroesophageal adenocarcinoma (EGC) patients in the adjuvant setting. The study plans to enroll 25 patients from more than 10 sites across the United Kingdom. Patients who are Signatera-positive following neoadjuvant chemotherapy and surgery will forgo standard-of-care adjuvant chemotherapy and receive the investigational therapy for a maximum of eight cycles. Signatera will be used to measure MRD-positivity following surgery and serially thereafter, with MRD clearance serving as the primary endpoint.
DECIPHER（Developing ctDNA Guided Adjuvant Therapy for Gastroesophageal Cancer）是一个单臂、开放标签的II期试验，也是第一个评估HER2定向抗体药物联合物在胃食管腺癌(EGC)患者辅助治疗方面疗效的试验。该研究计划从英国10多个地点招募25名患者，选择在新辅助化疗和手术后Signatera阳性的患者放弃标准的辅助化疗，接受最多八个疗程的治疗。Signatera将被用来评估手术后及之后的MRD阳性率，MRD清除将作为主要终点。