NCT06538207已完成1 期
An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 9
- 主要终点
- Adverse event(AE)
研究概览
简要总结
This study is a multicenter, open-label, uncontrolled study to investigate the tolerability and safety of ONO-4578, ONO-4538, and standard of care in combination as first-line treatment in patients with metastatic pancreatic 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
- None
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
- •Pancreatic invasive ducatal adenocarcinoma
- •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-4578+ONO-4538+mFFX
Experimental
干预措施: ONO-4578 (Drug)
ONO-4578+ONO-4538+mFFX
Experimental
干预措施: ONO-4538 (Drug)
ONO-4578+ONO-4538+mFFX
Experimental
干预措施: Oxaliplatin (Drug)
ONO-4578+ONO-4538+mFFX
Experimental
干预措施: Levofolinate (Drug)
ONO-4578+ONO-4538+mFFX
Experimental
干预措施: Irinotecan (Drug)
ONO-4578+ONO-4538+mFFX
Experimental
干预措施: Fluorouracil (Drug)
ONO-4578+ONO-4538+GnP
Experimental
干预措施: ONO-4578 (Drug)
ONO-4578+ONO-4538+GnP
Experimental
干预措施: ONO-4538 (Drug)
ONO-4578+ONO-4538+GnP
Experimental
干预措施: Gemcitabine (Drug)
ONO-4578+ONO-4538+GnP
Experimental
干预措施: Nab-Paclitaxel (Drug)
结局指标
主要结局
Adverse event(AE)
时间窗: UP to 28 days after the last dose
Dose-limiting toxicities（DLT）
时间窗: 28 days
次要结局
- Duration of response (DOR)(Up to 2 years)
- Overall response rate (ORR)(Up to 2 years)
- Pharmacokinetics (Serum concentration for ONO-4538)(Up to 28 days after the last dose)
- Disease control rate (DCR)(Up to 2 years)
- Progression-free survival (PFS)(Up to 2 years)
- Time to response (TTR)(Up to 2 years)
- Percentage of change in the sum of tumor diameters of target lesions(Up to 2 years)
- Maximum percentage of change in the sum of tumor diameters of target lesions(Up to 2 years)
- Pharmacokinetics (Plasma concentration for ONO-4578)(Up to 28 days after the last dose)
- Overall survival (OS)(Up to 2 years)
- Best overall response (BOR)(Up to 2 years)
- Changes in tumor markers (CEA and CA19-9)(Up to 2 years)
研究者
研究点 (9)
Loading locations...
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