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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. This is an open-lable, single arm, phase II trial, aims to evaluate efficacy and safety of JAK inhibitors for solid malignant tumor patients with ICI-related dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JAK inhibitors | Experimental | treated with JAK inhibitors orally for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JAK Inhibitor | Drug | JAK inhibitors for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of JAK inhibitors in adult patients with 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. | at any time |
| Explore the efficacy of JAK inhibitors in adult patients with ICI-related dermatitis. | The efficacy evaluated by the proportion of patients achieving relief from rashes (defined as ICI-related dermatitis grade ≤1according to CTCAE v5.0, ) | at baseline, 7, 14 ,21and 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| The change of pruritus severity | Pruritus severity assessed by Peak Pruritus Numerical Rating Scale (PP-NRS), score 0-10, a higher score indicates a more severe pruritus condition. | at baseline, 7, 14 ,21and 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 | Contact | +86-18983487900 | wushixiu@medmail.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quzhou people's hospital | Recruiting | Quzhou | Zhejiang | 324000 | China |
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| at 28 days |
| ID | Term |
|---|---|
| D000075242 | Janus Kinase Inhibitors |
| ID | Term |
|---|---|
| D047428 | Protein Kinase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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