An Open-Label, Single-Arm Exploratory Clinical Study of Everolimus for the Treatment of Vascular Malformations

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXuanwu Hospital, Beijing

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

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

Xuanwu Hospital, Beijing

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Collaborator