NCT06393972尚未招募2 期
The Efficacy and Safety of Tofacitinib in Patients With Glucocorticoid Resistant ICIs-related Myocarditis: a Single-arm, Prospective, Phase 2 Trial
Shanghai Zhongshan Hospital0 个研究点目标入组 25 人开始时间: 2024年7月1日最近更新:
适应症
干预措施
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
- 25
- 主要终点
- All-cause mortality within three months
研究概览
简要总结
The efficacy and safety of Tofacitinib in patients with glucocorticoid resistant ICIs-related myocarditis: a single-arm, prospective, phase 2 trial
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Patients treated with ICI immunotherapy (monotherapy or combination), including anti-PD1, anti-PDL1, anti-CTLA4; and including any type of cancer (even those in which ICI is not currently approved by regulatory)
- •Definite, probable or possible ICI-induced myocarditis according to the diagnostic criteria of the most recent expert consensus recommendations (e.g27, to be updated with any new recommendations to be published)
- •corticosteroid-resistant ICI-myocarditis: Corticosteroid-resistant ICI-myocarditis is defined by the absence of decrease in troponin levels or the appearance/persistence of severity criteria despite receiving prednisone dose ≥0.5 mg/kg/day for ≥2 days.
- •Signature of informed consent before any trial procedure from the patient or legal representative or the close relative
- •Patients covered by social security regimen (excepting AME)
- •Withhold of ICI
排除标准
- •Untreated and/or uncontrolled bacterial, fungal, or viral infection Pregnancy, breast-feeding or planning to become pregnant during the study period
- •For women of childbearing age, lack of effective contraception throughout the duration of participation in the study
- •Being treated with tofacitinib within 3 months prior to inclusion Known hypersensitivity to abatacept or belatacept
- •Being treated with anti-thymoglobulin, or alemtuzumab within 6 weeks of the first scheduled dose of abatacept
- •Patient participating to another interventional study (RIPH 1 only) People under legal protection measure (tutorship, curatorship or safeguard measures)
研究组 & 干预措施
Tofacitinib
Experimental
Tofacitinib in patients with glucocorticoid resistant ICIs-related myocarditis
干预措施: Tofacitinib 5 MG BID (Drug)
结局指标
主要结局
All-cause mortality within three months
时间窗: The first three months after tofacitinib administration
All-cause mortality within three months
次要结局
- Safety and tolerability based on incidence of treatment-emergent adverse events(through study completion, an average of 1 year)
- Overall survival(From date of enrollment until the date of death from any cause, assessed up to 24 months")
- Progression-free survival(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
- All-cause mortality within six months(The firs six months after tofacitinib administration)
研究者
Tianshu Liu
Clinical Professor
Shanghai Zhongshan Hospital
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