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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
JAK inhibitors for 28 days
Quzhou people's hospital
Quzhou, Zhejiang, China
RECRUITINGEvaluate 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.
Time frame: 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, )
Time frame: at baseline, 7, 14 ,21and 28 days
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.
Time frame: at baseline, 7, 14 ,21and 28 days.
Explore the proportion of continued ICIs utilization at the end of JAK inhibitors treatment
Time frame: at 28 days
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