Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT07037238

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

Led by Xuanwu Hospital, Beijing · Updated on 2025-09-05

10

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

X

Xuanwu Hospital, Beijing

Lead Sponsor

C

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 61 18 and 61 65 years
  • No gender restrictions
  • Diagnosed with vascular malformation by MRI
  • No major surgery within the past 3 months
  • Able to swallow and retain oral medication without significant gastrointestinal issues
  • Able to provide peripheral blood samples for biomarker testing
  • Adequate organ and bone marrow function with specific blood count and liver/kidney function limits
  • Willing to sign informed consent and complete follow-up
  • For childbearing potential: agree to use effective contraception or abstain during treatment and 90 days after last dose; males must avoid sperm donation for 90 days after last dose
Not Eligible

You will not qualify if you...

  • Diagnosed with Hereditary Hemorrhagic Telangiectasia, Arteriovenous Malformation, or PTEN Hamartoma Tumor Syndrome
  • Prior participation in interventional trials targeting cerebral cavernous malformations
  • Current or recent malignant tumors except certain treated skin or carcinoma in situ cancers
  • Unable to undergo MRI or contraindications affecting MRI assessment
  • Modified Rankin Scale score of 5, respiratory failure, or severe bleeding needing life support
  • Severe renal failure or recent history of renal failure without effective treatment
  • Severe hepatic failure or recent uncontrolled symptoms related to liver failure
  • Current use of immunosuppressants or immunodeficiency
  • Use of medications that interfere with CYP3A4 enzyme activity
  • Presence of gastrointestinal disorders affecting drug absorption
  • Interstitial pneumonitis or severe asthma
  • Uncontrolled diabetes mellitus
  • Active drug or alcohol dependence affecting study adherence
  • First-degree relatives with sudden cardiac death before age 50
  • Active infections including hepatitis B, hepatitis C, or HIV
  • Pregnant or breastfeeding women
  • Known allergy to everolimus or related compounds
  • Other severe diseases or conditions that may affect safety or study data as determined by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

the Department of Neurosurgery, China International Neuroscience Institute, Xuanwu Hospital, Capital Medical University

Beijing, China

Actively Recruiting

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Research Team

T

Tao Hong, MD

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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