NCT06540261进行中（未招募）1 期
An Open-label, Uncontrolled Study of ONO-7913, ONO-4538 and the Standard of Care FOLFOX in Combination With Bevacizumab or Cetuximab as First-line Treatment in Patients With Unresectable Advanced or Recurrent Colorectal Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 65
- 试验地点
- 17
- 主要终点
- Dose-limiting toxicities（DLT）
研究概览
简要总结
To confirm the tolerability and safety of combined administration of ONO-7913, ONO-4538 and the standard of care FOLFOX in combination with bevacizumab or cetuximab as first-line treatment in patients with unresectable advanced or recurrent colorectal cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable advanced or recurrent colorectal cancer
- •Life expectancy of at least 3 months
- •Patients with ECOG performance status 0 or 1
排除标准
- •Patients with severe complication
- •Patients with multiple primary cancers
研究组 & 干预措施
ONO-7913＋ONO-4538＋FOLFOX＋Bev
Experimental
干预措施: ONO-7913 (Drug)
ONO-7913＋ONO-4538＋FOLFOX＋Bev
Experimental
干预措施: ONO-4538 (Drug)
ONO-7913＋ONO-4538＋FOLFOX＋Bev
Experimental
干预措施: Fluorouracil (Drug)
ONO-7913＋ONO-4538＋FOLFOX＋Bev
Experimental
干预措施: Oxaliplatin (Drug)
ONO-7913＋ONO-4538＋FOLFOX＋Bev
Experimental
干预措施: Levofolinate (Drug)
ONO-7913＋ONO-4538＋FOLFOX＋Bev
Experimental
干预措施: Bevacizumab (Drug)
ONO-7913＋ONO-4538＋FOLFOX＋Cet
Experimental
干预措施: ONO-7913 (Drug)
ONO-7913＋ONO-4538＋FOLFOX＋Cet
Experimental
干预措施: Oxaliplatin (Drug)
ONO-7913＋ONO-4538＋FOLFOX＋Cet
Experimental
干预措施: ONO-4538 (Drug)
ONO-7913＋ONO-4538＋FOLFOX＋Cet
Experimental
干预措施: Fluorouracil (Drug)
ONO-7913＋ONO-4538＋FOLFOX＋Cet
Experimental
干预措施: Levofolinate (Drug)
ONO-7913＋ONO-4538＋FOLFOX＋Cet
Experimental
干预措施: Cetuximab (Drug)
结局指标
主要结局
Dose-limiting toxicities（DLT）
时间窗: 28 days
Adverse event (AE)
时间窗: Up to 30 days after the last dose
次要结局
- Overall Survival (OS)(Through study completion, an average of 3 years.)
- Pharmacokinetics（Plasma concentration of ONO-4538）(Through study completion, an average of 1 year.)
- Early Tumor shrinkage（ETS）(Up to 8 weeks)
- Duration of Response (DOR)(Through study completion, an average of 1 years.)
- Progression-Free Survival (PFS)(Through study completion, an average of 1 years.)
- Percent change in the sum diameters of the target lesions(Through study completion, an average of 1 years.)
- Pharmacokinetics（Plasma concentration of ONO-7913）(Through study completion, an average of 1 year.)
- Disease Control Rate (DCR)(Through study completion, an average of 1 year.)
- Time to Response (TTR)(Through study completion, an average of 1 years.)
- Objective Response Rate (ORR)(Through study completion, an average of 1 year.)
- Best Overall Response (BOR)(Through study completion, an average of 1 years.)
- Maximum percent change in the sum diameters of the target lesions(Through study completion, an average of 1 years.)
- Change From Baseline in Tumour Biomarkers (CEA and CA19-9)(Through study completion, an average of 1 year.)
研究者
研究点 (17)
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