About this trial
This study is a single-arm exploratory trial conducted by Xuanwu Hospital, Capital Medical University, aiming to evaluate the efficacy and safety of everolimus monotherapy in adult patients with vascular malformations.
Eligibility criteria
Qualifiers
Patients aged ≥18 and ≤65 years;
No gender restrictions;
Diagnosed with vascular malformation by MRI;
No major surgery within the past 3 months;
Disqualifiers
Diagnosed with Hereditary Hemorrhagic Telangiectasia (HHT), Arteriovenous Malformation (AVM), or PTEN Hamartoma Tumor Syndrome (PHTS);
Patients who have previously received any of the following treatments after birth: participation in other interventional clinical trials targeting cerebral cavernous malformations (CM);
Presence of malignant tumors currently or within the past three years, except for curatively treated non-melanoma skin basal cell carcinoma, ductal carcinoma in situ of the breast, or cervical carcinoma in situ;
Unable to undergo MRI scans and/or have contraindications for MRI (e.g., interference from prosthetics, orthodontic devices, etc., affecting target lesion volume analysis on MRI);
Trial design
Treatments tested in this trial
- Everolimus 10mg daily
Treatment groups
Sponsors and collaborators
Xuanwu Hospital, Beijing
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborator