Different Doses of Sirolimus for the Treatment of Cystic Lymphatic Malformations
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Presenting a LM with the following characteristics: 1. Male and female; 2. Between 0 and 18 years of age; 3. LM diagnosis was confirmed by local investigators and by consensus of our multidisciplinary vascular anomaly group at the West China Hospital of Sichuan University based on: Biopsy; Compatible MRI findings; History and clinical features. Exclusion Criteria: 1. Patients contraindicated for the administration of sirolimus (e.g., those with an allergy to sirolimus or other rapamycin analog) 2. Exposure to chemotherapy, embolization, corticosteroids, propranolol, sclerotherapy or any other investigational agents within 1 weeks before enrolment on study; 3. Patients had a history of a major surgery within 2 weeks before enrollment; 4. Patients who have a history of treatment with sirolimus or other mTOR inhibitor; 5. Any known evidence of significant local or systemic uncontrolled infection, defined as receiving intravenous antibiotics at the time of enrollment;