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Набор скоро начнётся NCT07530224

JAK Inhibitors for Solid Malignant Tumor Patients With Refractory Immune Checkpoint Inhibitors-related Dermatitis

Фаза II С лечением Immune Checkpoint Inhibitor-Induced Dermatitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: treated with JAK inhibitors orally for 28 days.
Кому может быть актуально
Состояния в реестре: Immune Checkpoint Inhibitor-Induced Dermatitis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

  • Препарат treated with JAK inhibitors orally for 28 days
    treated with JAK inhibitors (upadacitinib 15mg qd/tofacitinib 5mg bid)orally for 28 days

Первичные конечные точки

  • Explore the efficacy of JAK inhibitors in adult patients with refractory ICI-related dermatitis. [Срок оценки: At the end of treatment at day 28]
  • Evaluate the safety of JAK inhibitors in adult patients with refractory ICI-related dermatitis [Срок оценки: During the period of medication（28 days） and follow-up（2 months after discontinuation of the drug）]
Вторичные конечные точки (2)
  • The change of pruritus severity [Срок оценки: From enrollment to the end of treatment at 28 days]
  • Explore the proportion of continued ICIs utilization at the end of JAK inhibitors treatment [Срок оценки: At the end of treatment at day 28]

Критерии участия

Критерии включения

  • 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 6. All participants must be capable of providing personally signed and dated informed consent, demonstrating understanding of all relevant study aspects.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Quzhou people's hospital — Quzhou

Идентификаторы

NCT: NCT07530224 · 2025-105

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗