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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
treated with JAK inhibitors (upadacitinib 15mg qd/tofacitinib 5mg bid)orally for 28 days
Quzhou people's hospital
Quzhou, Zhejiang, China
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, )
Time frame: 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.
Time frame: During the period of medication(28 days) and follow-up(2 months after discontinuation of the drug)
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)
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.