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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JAK inhibitors | Experimental | treated with JAK inhibitors (upadacitinib 15mg qd/tofacitinib 5mg bid)orally for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treated with JAK inhibitors orally for 28 days | Drug | treated with JAK inhibitors (upadacitinib 15mg qd/tofacitinib 5mg bid)orally for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Explore the efficacy of JAK inhibitors in adult patients with refractory ICI-related dermatitis. | The efficacy evaluated by the proportion of patients with rashes relief (defined as ICI-related dermatitis grade ≤1according to CTCAE v5.0, ) | At the end of treatment at day 28 |
| Evaluate the safety of JAK inhibitors in adult patients with refractory ICI-related dermatitis | 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. | During the period of medication(28 days) and follow-up(2 months after discontinuation of the drug) |
| Measure | Description | Time Frame |
|---|---|---|
| The change of pruritus severity | Pruritus severity assessed by the time to achieve a 4-point improvement on the Peak Pruritus Numerical Rating Scale (PP-NRS) | From enrollment to the end of treatment at 28 days |
| Explore the proportion of continued ICIs utilization at the end of JAK inhibitors treatment |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shixiu Wu, MD | Contact | 08618983487900 | rainxl@foxmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quzhou people's hospital | Quzhou | Zhejiang | 324000 | China |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| At the end of treatment at day 28 |