JAK Inhibitors for Solid Malignant Tumor Patients With Immune Checkpoint Inhibitors-related Dermatitis: A Open-lable, Single Arm, Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Evaluate the safety of JAK inhibitors in adult patients with ICI-related dermatitis.
研究概览
简要总结
Currently, the principal strategy for immune checkpoint inhibitors (ICI)-related dermatitis include systemic use of corticosteroids, which can impair the efficacy of preceding ICIs treatment. Janus kinase inhibitors (JAKi) could be the optimal option for ICI-related dermatitis, which can not only provide rapid relief for ICI-related dermatitis but also potentially enhance the anti-tumor efficacy of ICIs. This is an open-lable, single arm, phase II trial, aims to evaluate efficacy and safety of JAK inhibitors for solid malignant tumor patients with ICI-related dermatitis.
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 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
JAK inhibitors
treated with JAK inhibitors orally for 28 days
干预措施: JAK Inhibitor (Drug)
结局指标
主要结局
Evaluate the safety of JAK inhibitors in adult patients with ICI-related dermatitis.
时间窗: at any time
The safty will be assessed based on the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during upadacitinib treatment. The severity of AEs will be graded using NCI CTCAE v5.0.
Explore the efficacy of JAK inhibitors in adult patients with ICI-related dermatitis.
时间窗: at baseline, 7, 14 ,21and 28 days
The efficacy evaluated by the proportion of patients achieving relief from rashes (defined as ICI-related dermatitis grade ≤1according to CTCAE v5.0, )
次要结局
- The change of pruritus severity(at baseline, 7, 14 ,21and 28 days.)
- Explore the proportion of continued ICIs utilization at the end of JAK inhibitors treatment(at 28 days)
研究者
Shixiu Wu
professor
Hangzhou Cancer Hospital