An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a multicenter, non-randomized, umbrella, open-label phase II clinical study, aiming to observe and evaluate, as well as explore the efficacy and safety of precision targeted therapy based on NGS technology for IDH1-mutated patients, specifically the combination of ivosidenib with multi-target tyrosine kinase inhibitors represented by lenvatinib or PD-1/PD-L1 in advanced biliary tract cancer patients who have failed systemic chemotherapy.
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
- 18 Years 至 80 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
Ivosidenib Monotherapy
干预措施: Ivosidenib (Drug)
Ivosidenib + Lenvatinib
干预措施: Ivosidenib (Drug)
Ivosidenib + Lenvatinib
干预措施: Lenvatinib (Drug)
Ivosidenib + PD-1/PD-L1 Inhibitor
干预措施: Ivosidenib (Drug)
Ivosidenib + PD-1/PD-L1 Inhibitor
干预措施: PD-1/PD-L1 inhibitor (Biological)
Ivosidenib + Lenvatinib + PD-1/PD-L1 Inhibitor
干预措施: Ivosidenib (Drug)
Ivosidenib + Lenvatinib + PD-1/PD-L1 Inhibitor
干预措施: Lenvatinib (Drug)
Ivosidenib + Lenvatinib + PD-1/PD-L1 Inhibitor
干预措施: PD-1/PD-L1 inhibitor (Biological)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From first dose of study drug until disease progression, death, or start of new anti-cancer therapy, assessed up to approximately 24 months.
次要结局
- Disease Control Rate (DCR)(From first dose of study drug until disease progression, death, or start of new anti-cancer therapy, assessed up to approximately 24 months.)
- Progression-Free Survival (PFS)(From first dose of study drug until disease progression or death from any cause (whichever occurs first), assessed up to approximately 24 months.)
- Overall Survival (OS)(From enrollment (or first dose) until death from any cause, assessed up to approximately 36 months.)
- Duration of Response (DOR)(From the date of first documented response (CR or PR) until the date of disease progression or death, assessed up to approximately 24 months.)