JAK Inhibitors for Solid Malignant Tumor Patients With Immune Checkpoint Inhibitors-related Dermatitis: A Open-lable, Single Arm, Phase II Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Evaluate the safety of JAK inhibitors in adult patients with ICI-related dermatitis.
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
JAK inhibitors
treated with JAK inhibitors orally for 28 days
Intervention: JAK Inhibitor (Drug)
Outcomes
Primary Outcomes
Evaluate the safety of JAK inhibitors in adult patients with ICI-related dermatitis.
Time Frame: at any time
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.
Explore the efficacy of JAK inhibitors in adult patients with ICI-related dermatitis.
Time Frame: at baseline, 7, 14 ,21and 28 days
The efficacy evaluated by the proportion of patients achieving relief from rashes (defined as ICI-related dermatitis grade ≤1according to CTCAE v5.0, )
Secondary Outcomes
- The change of pruritus severity(at baseline, 7, 14 ,21and 28 days.)
- Explore the proportion of continued ICIs utilization at the end of JAK inhibitors treatment(at 28 days)
Investigators
Shixiu Wu
professor
Hangzhou Cancer Hospital