JAK Inhibitors for Solid Malignant Tumor Patients With Refractory Immune Checkpoint Inhibitors-related Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: treated with JAK inhibitors orally for 28 days.
- Who it may be relevant to
- Registry conditions: Immune Checkpoint Inhibitor-Induced Dermatitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug treated with JAK inhibitors orally for 28 days
treated with JAK inhibitors (upadacitinib 15mg qd/tofacitinib 5mg bid)orally for 28 days
Primary outcome measures
- Explore the efficacy of JAK inhibitors in adult patients with refractory ICI-related dermatitis. [Time frame: At the end of treatment at day 28]
- Evaluate the safety of JAK inhibitors in adult patients with refractory ICI-related dermatitis [Time frame: During the period of medication（28 days） and follow-up（2 months after discontinuation of the drug）]
Secondary outcome measures (2)
- The change of pruritus severity [Time frame: From enrollment to the end of treatment at 28 days]
- Explore the proportion of continued ICIs utilization at the end of JAK inhibitors treatment [Time frame: At the end of treatment at day 28]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Quzhou people's hospital — Quzhou
Identifiers
NCT: NCT07530224 · 2025-105