ONO-4578-08:A randomized, multicenter, double-blind, phase 2 study to compare the efficacy and safety of thetreatment with ONO-4578 in combination with nivolumab, fluoropyrimidine-based and platinum-based chemotherapy (hereinafter referred to as chemotherapy) with those of the treatment withplacebo in combination with nivolumab and chemotherapy in chemotherapy-naive participantswith human epidermal growth factor receptor 2 (HER2)-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer)

Hirashima Yoshinori0 个研究点目标入组 210 人开始时间: 2023年10月12日最近更新: 2024年4月1日

适应症

试验速览

暂无简介。

•1. Patients with gastric or esophagogastric junction cancer histologically diagnosed as adenocarcinoma
•2. Patients have not been treated with systemic chemotherapy as first-line therapy
•3. Patients who can provide tumor tissue samples

•1. Patients unable to take oral medicines
•2. Patients with HER2-positive
•3. Patients with contraindications to nivolumab, oxaliplatin, S-1, or capecitabine
•4. Patients who have a history of severe drug-related adverse reactions caused by non-steroidal anti-inflammatory drugs (NSAIDs) or who have complications caused by NSAIDs requiring treatment
•5. Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, such as rheumatoid arthritis
•6. Patients with headache and/or nausea associated with brain metastasis

发起方

Hirashima Yoshinori