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Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety of different concentration gradients of sirolimus in the treatment of Kaposiform hemangioendothelioma.


Clinical Trial Description

Kaposiform hemangioendothelioma (KHE) is a rare aggressive vascular neoplasm that occurs predominantly in infancy or early childhood, with an incidence of approximately 0.71/100,000. Currently, sirolimus is a promising treatment modality for KHE. Most scholars consider sirolimus blood concentration of 5-15 ng/ml to be an effective therapeutic concentration. However, long-term higher dose sirolimus treatment can cause some common complications such as oral mucositis which affects the quality of life of the patient. Finer control of the plasma concentration of sirolimus may contribute to the efficacy of treatment and reduce the incidence of complications. Therefore, we conducted this study to see if low-dose sirolimus is beneficial to the prognosis of patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04775173
Study type Interventional
Source West China Hospital
Contact
Status Completed
Phase Phase 2
Start date February 17, 2021
Completion date August 10, 2023

See also
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Completed NCT04077515 - Safety and Efficacy of Low-dose Sirolimus to Kaposiform Hemangioendothelioma Phase 4
Recruiting NCT05351216 - The Effect of Sirolimus on Immunizations During the Treatment of Kaposiform Hemangioendothelioma
Completed NCT03188068 - Sirolimus Versus Sirolimus Plus Prednisolone for Kaposiform Hemangioendothelioma Phase 2
Completed NCT04448873 - Guided Discontinuation Versus Maintenance Treatment of Sirolimus in Pediatric Patients With Kaposiform Hemangioendothelioma Phase 4
Recruiting NCT03001180 - Identification of Biomarkers for Patients With Vascular Anomalies