Guided Discontinuation Versus Maintenance Treatment of Sirolimus in Pediatric Patients With Kaposiform Hemangioendothelioma

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized controlled trial aims to compare guided discontinuation with maintenance treatment of sirolimus in pediatric patients with KHE.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Fudan University
• Treatments: Sirolimus

Criteria

Inclusion Criteria:

• Participant diagnosed with KHE with or without KMP

• Participant age 0-12 years

• Participant with detailed medical records of the disease at the time of screening

• Participant with at least two years of remission of KHE and no previous toxicity or adverse events

• Participant with normal liver and kidney function

• Participant with signed and dated informed consent from the guardian(s)

Exclusion Criteria:

• Participant with other hematological diseases

• Participant with other solid tumor

• Participant with general disease such as hypertension, diabetes, adrenal insufficiency, neurological diseases, liver and kidney dysfunction, and cardiopulmonary insufficiency.

• Participant with infectious diseases

• Unwilling participant