JAK Inhibitors for Solid Malignant Tumor Patients With Refractory Immune Checkpoint Inhibitors-related Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Explore the efficacy of JAK inhibitors in adult patients with refractory 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 with minimal adverse events. This is an open-lable, phase II trial, aims to evaluate efficacy and safety of JAK inhibitors for solid malignant tumor patients with refractory 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be at least 18 years of age
- •Clinical diagnosis of solid malignant tumor.
- •Patients who have received treatment with any Food and Drug Administration (FDA)-approved monoclonal antibodies targeting CTLA-4, PD-1, or PD-L1, either as monotherapy or in combination.
- •Clinical diagnosis of Immune checkpoint inhibitors (ICI)-related dermatitis graded as 3-4
- •Patients with ICI-related dermatitis who were refractory to previous treatment with corticosteroids and/or immunosuppressive agents.
- •Adequate bone marrow and organ function, as outlined below, must be confirmed:
- •1) White blood cell (WBC) count ≥ 2.0 × 10⁹/L 2) Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L 3) Platelet count (PLT) ≥ 75 × 10⁹/L 4) Hemoglobin (Hgb) ≥ 90 g/L 5) AST and ALT ≤ 3 × upper limit of normal (ULN) in patients without hepatic metastases; ≤ 5 × ULN in those with hepatic metastases, provided the elevation is not attributable to ICI-related hepatitis 6) Total bilirubin ≤ 2 × ULN, except in cases of Gilbert's syndrome (where total bilirubin must be < 3.0 mg/dL), and not due to ICI-related hepatotoxicity
- •All participants must be capable of providing personally signed and dated informed consent, demonstrating understanding of all relevant study aspects.
排除标准
- •Clinical diagnosis of dermatological diseases (e.g., chronic inflammatory skin disorders such as atopic dermatitis or psoriasis) that, in the investigator's assessment, may elevate the risks associated with study participation or compromise the interpretation of study outcomes.
- •Female who is pregnant, breastfeeding, or considering pregnancy during the study.
- •Current or past history of infection including herpes zoster or herpes simplex, human immunodeficiency virus (HIV), active Tuberculosis, active or chronic recurring infection, active hepatitis B or C.
- •Patients with ICI-related dermatitis who were either treatment-naïve (having received no prior steroids or immunosuppressants)
- •Any other medical, psychiatric, or logistical condition that, in the judgment of the investigator, could pose a safety risk, affect protocol compliance, or interfere with the conduct or interpretability of the study.
研究组 & 干预措施
JAK inhibitors
treated with JAK inhibitors (upadacitinib 15mg qd/tofacitinib 5mg bid)orally for 28 days
干预措施: treated with JAK inhibitors orally for 28 days (Drug)
结局指标
主要结局
Explore the efficacy of JAK inhibitors in adult patients with refractory ICI-related dermatitis.
时间窗: At the end of treatment at day 28
The efficacy evaluated by the proportion of patients with rashes relief (defined as ICI-related dermatitis grade ≤1according to CTCAE v5.0, )
Evaluate the safety of JAK inhibitors in adult patients with refractory ICI-related dermatitis
时间窗: During the period of medication（28 days） and follow-up（2 months after discontinuation of the drug）
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.
次要结局
- The change of pruritus severity(From enrollment to the end of treatment at 28 days)
- Explore the proportion of continued ICIs utilization at the end of JAK inhibitors treatment(At the end of treatment at day 28)
研究者
Shixiu Wu
Professor
Hangzhou Cancer Hospital