A Feasibility Trial of Nivolumab With Neoadjuvant CF or DCF Therapy for Locally Advanced Esophageal Carcinoma FRONTiER Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Rate of participants with dose limiting toxicities (DLTs)
研究概览
简要总结
The main purpose of this study is to evaluate the safety of the neoadjuvant therapy, nivolumab with CF (5-FU, CDDP) or nivolumab with DCF (5-FU, CDDP, DTX), for locally advanced esophageal carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort A
"Nivolumab: 360 mg, every 3 week 5-FU: 800 mg/m^2, every 3 week CDDP: 80 mg/m^2, every 3 week "
干预措施: Nivolumab (Biological)
Cohort A
"Nivolumab: 360 mg, every 3 week 5-FU: 800 mg/m^2, every 3 week CDDP: 80 mg/m^2, every 3 week "
干预措施: 5-FU (Drug)
Cohort A
"Nivolumab: 360 mg, every 3 week 5-FU: 800 mg/m^2, every 3 week CDDP: 80 mg/m^2, every 3 week "
干预措施: CDDP (Drug)
Cohort B
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 800 mg/m^2, every 3 week CDDP: 80 mg/m^2, every 3 week "
干预措施: Nivolumab (Biological)
Cohort B
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 800 mg/m^2, every 3 week CDDP: 80 mg/m^2, every 3 week "
干预措施: 5-FU (Drug)
Cohort B
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 800 mg/m^2, every 3 week CDDP: 80 mg/m^2, every 3 week "
干预措施: CDDP (Drug)
Cohort C
"Nivolumab: 360 mg, every 3 week 5-FU: 750 mg/m^2, every 3 week CDDP: 70 mg/m^2, every 3 week DTX: 70mg/m^2, every 3 weeks"
干预措施: Nivolumab (Biological)
Cohort C
"Nivolumab: 360 mg, every 3 week 5-FU: 750 mg/m^2, every 3 week CDDP: 70 mg/m^2, every 3 week DTX: 70mg/m^2, every 3 weeks"
干预措施: 5-FU (Drug)
Cohort C
"Nivolumab: 360 mg, every 3 week 5-FU: 750 mg/m^2, every 3 week CDDP: 70 mg/m^2, every 3 week DTX: 70mg/m^2, every 3 weeks"
干预措施: CDDP (Drug)
Cohort C
"Nivolumab: 360 mg, every 3 week 5-FU: 750 mg/m^2, every 3 week CDDP: 70 mg/m^2, every 3 week DTX: 70mg/m^2, every 3 weeks"
干预措施: DTX (Drug)
Cohort D
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 750 mg/m^2, every 3 week CDDP: 70 mg/m^2, every 3 week DTX: 70mg/m^2, every 3 weeks"
干预措施: Nivolumab (Biological)
Cohort D
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 750 mg/m^2, every 3 week CDDP: 70 mg/m^2, every 3 week DTX: 70mg/m^2, every 3 weeks"
干预措施: 5-FU (Drug)
Cohort D
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 750 mg/m^2, every 3 week CDDP: 70 mg/m^2, every 3 week DTX: 70mg/m^2, every 3 weeks"
干预措施: CDDP (Drug)
Cohort D
"Nivolumab: 240 mg lead-in followed by 360 mg, every 3 week 5-FU: 750 mg/m^2, every 3 week CDDP: 70 mg/m^2, every 3 week DTX: 70mg/m^2, every 3 weeks"
干预措施: DTX (Drug)
结局指标
主要结局
Rate of participants with dose limiting toxicities (DLTs)
时间窗: from initial dose to 30 post-operative days
To evaluate the safety of combination chemotherapy with nivolumab as neoadjuvant Tx
次要结局
- Adverse event (AE) expression rate(up to 30 postoperative days)
- Pathological complete response rate(from baseline to operation, average of 10 weeks after initial dose)
- Overall survival (OS)(from baseline to date of death, approximately 24 month)
- Response rate (RR): percentage of participants with with a best response of CR or PR(from baseline to date of disease progression, approximately 24 months)
- Radical resection rate(at operation, average of 10 weeks after initial dose)
- Treatment completion rate(from baseline to operation, average of 10 weeks after initial dose)
- Progression-free survival (PFS)(from baseline to date of disease progression or death, approximately 24 month)