NCT07692451尚未招募2 期
A Randomized Controlled Study of Fosrolapitant and Palonosetron for the Prevention of Nausea and Vomiting Induced by Antibody-Drug Conjugates in Cancer Patients
Peking University Cancer Hospital & Institute0 个研究点目标入组 124 人开始时间: 2026年7月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 主要终点
- Complete response rate
研究概览
简要总结
This study is aimed to evaluate the efficacy and safety of Fosrolapitant and Palonosetron for Antibody-drug conjugate-induced nausea and vomiting
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18 years of age or older, of either gender
- •Has a diagnosed malignant tumor
- •has never been treated with ADCs and is to receive the first course of ADCs
- •Predicted life expectancy of ≥ 3 months
- •Has a performance status (ECOG scale) of 0 to 1
- •Adequate bone marrow, kidney, and liver function
- •Women of childbearing potential must have negative pregnancy test (serum test) results within 72 hours prior to enrollment
- •Able and willing to provide a written informed consent
结局指标
主要结局
Complete response rate
时间窗: Within 14 days after ADC administration
次要结局
未报告次要终点
研究者
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