A Prospective Exploratory Phase II Study of Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for the Treatment of HER2-positive Advanced Biliary Tract Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- ORR, objective response rate
研究概览
简要总结
This trial is a single-arm exploratory phase II clinical study initiated by the investigator.
Subjects who met the research criteria were screened and enrolled to receive the treatment regimen of disitamab vedotin combined with lenvatinib and PD-1 inhibitor. During the treatment process, the researchers closely followed up, strictly evaluated the efficacy, assessed the efficacy and safety of the subjects after receiving the combined treatment, evaluated the subjects until progression occurred, and observed their objective response rate, progression-free survival, overall survival, disease control rate, duration of response, and safety evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Disitamab vedotin combined with lenvatinib and PD-1 inhibitor
Disitamab vedotin combined with lenvatinib and PD-1 inhibitor (Pembrolizumab or Toripalimab or Camrelizumab)
干预措施: Disitamab Vedotin (Drug)
Disitamab vedotin combined with lenvatinib and PD-1 inhibitor
Disitamab vedotin combined with lenvatinib and PD-1 inhibitor (Pembrolizumab or Toripalimab or Camrelizumab)
干预措施: Lenvatinib (Drug)
Disitamab vedotin combined with lenvatinib and PD-1 inhibitor
Disitamab vedotin combined with lenvatinib and PD-1 inhibitor (Pembrolizumab or Toripalimab or Camrelizumab)
干预措施: Pembrolizumab (Drug)
Disitamab vedotin combined with lenvatinib and PD-1 inhibitor
Disitamab vedotin combined with lenvatinib and PD-1 inhibitor (Pembrolizumab or Toripalimab or Camrelizumab)
干预措施: Toripalimab (Drug)
Disitamab vedotin combined with lenvatinib and PD-1 inhibitor
Disitamab vedotin combined with lenvatinib and PD-1 inhibitor (Pembrolizumab or Toripalimab or Camrelizumab)
干预措施: Camrelizumab (Drug)
结局指标
主要结局
ORR, objective response rate
时间窗: 12 months after the last subject is enrolled
次要结局
- DCR, disease control rate(12 months after the last subject is enrolled)
- PFS, progression free survival(12 months after the last subject is enrolled)
- DoR, duration of response(12 months after the last subject is enrolled)
- OS, overall survival(12 months after the last subject is enrolled)
- Adverse events (AE) and serious adverse events (SAE)(12 months after the last subject is enrolled)