Natera Announces Enrollment Of First Patients In SAGITTARIUS A Randomized Phase III Clinical Trial In Colon Cancer; ~700-900 Patients Expected To Be Enrolled Across More Than 20 Sites
Natera Announces Enrollment Of First Patients In SAGITTARIUS A Randomized Phase III Clinical Trial In Colon Cancer; ~700-900 Patients Expected To Be Enrolled Across More Than 20 Sites
The study aims to enroll approximately 700-900 stage III and high-risk stage II colon cancer patients following surgical resection.SAGITTARIUS is Natera's first interventional trial using SignateraTM to select patients for targeted therapy in early-stage colon cancer
SAGITTARIUS是Natera首次使用SignateraTm選擇早期結腸癌患者進行靶向治療的干預試驗。
Approximately 700-900 patients expected to be enrolled across more than 20 sites
預計將在超過20個地點招募約700-900名患者。
Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA and genetic testing, today announced the enrollment of the first patients in the SAGITTARIUS clinical trial. Sponsored by The AIRC Institute of Molecular Oncology (IFOM-ETS) and funded by the European Union Horizon Europe Programme, SAGITTARIUS is a global, randomized, phase III clinical trial designed to evaluate the use of Signatera to guide personalized adjuvant treatment strategies for patients with colon cancer.
Natera, Inc. (納斯達克:NTRA)是一家全球領先的無細胞DNA和基因檢測公司，今天宣佈SAGITTARIUS臨床試驗的第一批患者已被招募。該試驗由分子腫瘤學AIRC研究所（IFOm-ETS）贊助，並由歐洲聯盟地平線歐洲項目資助，SAGITTARIUS是一項全球隨機三期臨床試驗，旨在評估使用Signatera指導個性化輔助治療策略的有效性，以治療結腸癌患者。
The study aims to enroll approximately 700-900 stage III and high-risk stage II colon cancer patients following surgical resection.
該研究旨在招募約700-900名經過手術切除的III期和高風險II期結腸癌患者。
- Signatera-positive patients will be randomized to receive either genotype-guided therapy tailored to their individual tumor mutational profile or six months of standard chemotherapy. The trial's investigational arm will explore the potential of administering immunotherapy or targeted agents approved for metastatic colon cancer earlier in the disease course to increase the proportion of patients cured with adjuvant therapy. This genomically-driven approach will focus on mismatch repair status, POLE, RAS/RAF mutation status, and HER2 amplification status.
- For Signatera-negative patients, the trial will compare physician choice treatments with options for de-escalation to observation or single-agent capecitabine for six months.
- Signatera陽性患者將被隨機分配接受根據其個體腫瘤突變譜定製的基因型指導療法或六個月的標準化療。該試驗的研究性療程將探討在疾病初期早期接受已批准用於轉移性結腸癌的免疫療法或靶向藥物的潛力，以增加通過輔助治療治癒的患者比例。該基因組驅動的方法將重點關注錯配修復狀態、POLE、RAS/RAF突變狀態和HER2擴增狀態。
- 對於Signatera陰性患者，試驗將比較醫生選擇的治療與觀察或單一藥物卡培他濱六個月的降級選項。
SAGITTARIUS includes collaborations with 9 partners in 5 countries in Europe, and a network of 26 clinical centers in Italy, Spain, and Germany.
SAGITTARIUS包括與歐洲5個國家的9個合作伙伴的合作，以及在意大利、西班牙和德國的26個臨床中心的網絡。
譯文內容由第三人軟體翻譯。