Sirolimus in the Treatment for Infantile Hepatic Hemangioendothelioma(IEEH)

• Status: Not yet recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Infantile hepatic hemangioendothelioma (IHHE) is an infantile hemangioma involving the liver.Since 2008, propranolol has been used for the treatment of hemangioma, and some researchers have also started to report the use of propranolol for the treatment of infantile hepatic hemangioma in children. Sirolimus can be used in patients with vascular malformations such as hemangiomas. IHHE is also an infantile hemangioma involving the liver,thus sirolimus may paly the role in treatment of IHHE.The clinical trial explores the efficacy of sequential treatment of sirolimus to refractory IHHE patients resistant with propranolol, to improve the therapeutic effect, reduce the side effects of traditional treatment methods (hormones, interferon), and reduce the number of operations and interventions and to provide a clinical basis for the application of the new therapeutics model of IHHE of "propranolol + sequential sirolimus treatment".

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

Details

• Lead Sponsor: Shanghai Children's Medical Center
• Treatments: Propranolol; Sirolimus

Criteria

Inclusion Criteria:

• Confirmed as IHHE

• Age between 1 month and 36 months

• Receiving propranolol for 3 months but the tumor size shrinks <30%

• With written informed consent

Exclusion Criteria:

• Confirmed as hepatoblastoma

• Have accepted surgical resection

• Clinical data missing

• Patients with Kasabach-Merritt phenomenon

• Receiving propranolol for 3 months and the tumor size shrinks >30%