Actively Recruiting
Different Doses of Sirolimus for the Treatment of Cystic Lymphatic Malformations
Led by West China Hospital · Updated on 2024-12-31
150
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to compare the efficacy and safety of different concentration gradients of sirolimus in the treatment of cystic lymphatic malformation.
CONDITIONS
Official Title
Different Doses of Sirolimus for the Treatment of Cystic Lymphatic Malformations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients
- Between 0 and 18 years of age
- Confirmed diagnosis of lymphatic malformation by biopsy, compatible MRI findings, history, and clinical features as agreed by local investigators and a multidisciplinary vascular anomaly group
You will not qualify if you...
- Allergy or contraindication to sirolimus or related drugs
- Use of chemotherapy, embolization, corticosteroids, propranolol, sclerotherapy, or other investigational agents within 1 week before study enrollment
- Major surgery within 2 weeks before enrollment
- Previous treatment with sirolimus or other mTOR inhibitors
- Evidence of significant local or systemic uncontrolled infection requiring intravenous antibiotics at enrollment
- Severe or uncontrolled medical diseases that could affect study participation, such as uncontrolled diabetes, hypertension, severe malnutrition, chronic liver or kidney disease, or active upper gastrointestinal ulcers
- Gastrointestinal dysfunction or chronic disease that may affect sirolimus absorption
- Inadequate liver function (total bilirubin ≥1.5 times upper limit of normal for age; alanine aminotransferase and aspartate aminotransferase ≥2.5 times upper limit of normal for age)
- Inadequate renal function based on age-specific serum creatinine thresholds
- Low bone marrow function (absolute neutrophil count below 1 × 10^9/L)
- History of malignancy within 5 years
- HIV infection or known immunodeficiency
- Need for corticosteroids, vincristine, interferon-alpha, sirolimus, or tacrolimus for other conditions
- Inability to participate in or comply with study treatment and assessments
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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