NCT06256328进行中（未招募）2 期
A Randomized, Multicenter, Double-blind, Phase II Study to Compare the Efficacy and Safety of the Treatment With ONO-4578 in Combination With Nivolumab, Fluoropyrimidine-based and Platinum- Based Chemotherapy (Hereinafter Referred to as Chemotherapy) With Those of the Treatment With Placebo in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 226
- 试验地点
- 63
- 主要终点
- Progression-free survival (PFS) (site investigator assessment)
研究概览
简要总结
This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy in chemotherapy-naïve participants with HER2- negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with gastric or esophagogastric junction cancer histologically diagnosed as adenocarcinoma
- •Patients have not been treated with systemic chemotherapy as first-line therapy
- •Patients who can provide tumor tissue samples
排除标准
- •Patients unable to take oral medicines
- •Patients with HER2-positive
- •Patients with contraindications to nivolumab, oxaliplatin, S-1, or capecitabine
- •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
- •Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, such as rheumatoid arthritis
- •Patients with headache and/or nausea associated with brain metastasis
研究组 & 干预措施
ONO-4578+Nivolumab+chemotherapy
Experimental
干预措施: ONO-4578 (Drug)
ONO-4578+Nivolumab+chemotherapy
Experimental
干预措施: S-1 (Drug)
ONO-4578+Nivolumab+chemotherapy
Experimental
干预措施: Oxaliplatin (Drug)
ONO-4578+Nivolumab+chemotherapy
Experimental
干预措施: Capecitabine (Drug)
ONO-4578+Nivolumab+chemotherapy
Experimental
干预措施: Nivolumab (Drug)
placebo+Nivolumab+chemotherapy
Placebo Comparator
干预措施: Oxaliplatin (Drug)
placebo+Nivolumab+chemotherapy
Placebo Comparator
干预措施: Capecitabine (Drug)
placebo+Nivolumab+chemotherapy
Placebo Comparator
干预措施: S-1 (Drug)
placebo+Nivolumab+chemotherapy
Placebo Comparator
干预措施: Nivolumab (Drug)
placebo+Nivolumab+chemotherapy
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-free survival (PFS) (site investigator assessment)
时间窗: up to 2years
次要结局
- Objective response rate (ORR) (site investigator assessment)(up to 2years)
- Adverse event (AE)(Up to 30 days after the last dose)
- Overall survival (OS)(up to 2years)
- Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)(up to 2years)
- Best overall response (BOR) (site investigator assessment)(up to 2years)
- Duration of response (DOR) (site investigator assessment)(up to 2years)
- Disease control rate (DCR) (site investigator assessment)(up to 2years)
- Time to response (TTR) (site investigator assessment)(up to 2years)
- Maximum percent change in the sum diameters of the target lesions (site investigator assessment)(up to 2years)
研究者
研究点 (63)
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