Actively Recruiting
JAK Inhibitors for Solid Malignant Tumor Patients With Immune Checkpoint Inhibitors-related Dermatitis: A Open-lable, Single Arm, Phase IIa Trial
Led by Shixiu Wu · Updated on 2025-10-28
35
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
JAK Inhibitors for Solid Malignant Tumor Patients With Immune Checkpoint Inhibitors-related Dermatitis: A Open-lable, Single Arm, Phase IIa Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old with a confirmed diagnosis of a solid malignant tumor
- Received treatment with any FDA-approved monoclonal antibodies targeting CTLA-4, PD-1, or PD-L1, alone or in combination
- Diagnosed with ICI-related dermatitis graded 3 or 4 according to CTCAE version 5.0
- Either treatment-naïve for ICI-related dermatitis or refractory to corticosteroids and/or immunosuppressive agents
- Adequate bone marrow and organ function as defined by specific blood counts and liver function tests
- Able to provide signed informed consent and understand study details
You will not qualify if you...
- Dermatological diseases like atopic dermatitis or psoriasis that may increase risks or affect study results
- Persistent dermatitis (grade >1) due to treatments other than ICIs
- Female who is pregnant, breastfeeding, or planning pregnancy during the study
- Current or past infections including herpes zoster, herpes simplex, HIV, active tuberculosis, or active hepatitis B or C
- Any other medical, psychiatric, or logistical condition posing safety risks or affecting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Quzhou people's hospital
Quzhou, Zhejiang, China, 324000
Actively Recruiting
Research Team
S
Shixiu Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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