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.
全球領先的電芯DNA和基因檢測公司Natera, Inc.（納斯達克:NTRA）今天宣佈推出一項新的胃食管癌臨床試驗DECIPHER，該試驗將利用該公司的個性化和腫瘤知情的分子殘留疾病（MRD）檢測——Signatera，指導病人選擇並評估正在接受胃食管癌治療的病人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）是一個單臂、開放標籤的II期試驗，也是第一個評估HER2定向抗體藥物聯合物在胃食管腺癌(EGC)患者輔助治療方面療效的試驗。該研究計劃從英國10多個地點招募25名患者，選擇在新輔助化療和手術後Signatera陽性的患者放棄標準的輔助化療，接受最多八個療程的治療。Signatera將被用來評估手術後及之後的MRD陽性率，MRD清除將作爲主要終點。