#Matterhorn startrail trial#Clinical trial registration: NCT04592913 (). The planned sample size is 900 patients, the primary end point is event-free survival and safety and tolerability will be evaluated. We describe the rationale for and the design of MATTERHORN, a randomized, double-blind, placebo-controlled, phase III study investigating the efficacy and safety of neoadjuvant-adjuvant durvalumab and FLOT chemotherapy followed by adjuvant durvalumab monotherapy in patients with resectable gastric/gastroesophageal junction cancer. Accumulating evidence indicates that ICIs combined with FLOT chemotherapy improve clinical outcomes in patients with advanced or metastatic cancer. Early-phase clinical studies support further clinical development of the immune checkpoint inhibitor (ICI) durvalumab, an anti-PD-L1 antibody, in patients with gastric/gastroesophageal junction cancer. Standard-of-care for resectable gastric/gastroesophageal junction cancer includes surgery and neoadjuvant-adjuvant 5-fluorouracil-leucovorin-oxaliplatin-docetaxel (FLOT) chemotherapy. 11 Medical Oncology Department, Vall d'Hebron Hospital Campus & Institute of Oncology (VHIO), IOB-Quiron, UVic-UCC, Barcelona, 08035, Spain.10 Global Clinical Development, AstraZeneca, Gaithersburg, MD 20878, USA.9 Global Clinical Development, AstraZeneca, Cambridge, CB2 8PA, UK.8 Statistics, AstraZeneca, Gaithersburg, MD 20878, USA.7 Esophageal Surgery Program, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.
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