A Phase 2 interventional study of Sirolimus in Kaposiform Hemangioendothelioma, sponsored by West China Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by West China Hospital · Phase 2, Interventional, and Treatment
Sirolimus has demonstrated efficacy in the treatment of kaposiform hemangioendothelioma (KHE); however, a high rate of rebound growth following discontinuation has been reported, highlighting the clinical importance of establishing an appropriate withdrawal regimen.
West China Hospital is the lead sponsor of 501 studies on the registry; 246 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sirolimus was gradually tapered and discontinued over a 2-month period.
Drug: Sirolimus
Sirolimus was administered using a 3-days-on/4-days-off weekly schedule for 6 months, followed by gradual tapering and discontinuation over 2 months.
Drug: Sirolimus
Comparison of different sirolimus discontinuation strategies.
Rebound growth rate of KHE
The primary endpoint is the rebound growth rate of KHE during the follow-up period.
Time frame: 12 months
Incidence of disease sequelae
Incidence of disease sequelae, assessed by the number of participants who develop clinically confirmed sequelae during the follow-up period, as determined through questionnaires and clinical plus imaging evaluations.
Time frame: 12 months
Incidence of adverse events throughout the study.
Incidence of adverse events during the follow-up period.
Time frame: 12 months
Plan to share: No
Started Sep 2025 (actual). Primary completion is estimated for Sep 2027, 23 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Sirolimus
Kaposiform Hemangioendothelioma