Clinical trial · Interventional
Safety and Efficacy of Low-dose Sirolimus to Kaposiform Hemangioendothelioma
Safety and Efficacy of Low-dose Sirolimus to Kaposiform Hemangioendothelioma:A Prospective, Randomized Open Trial
NCT04077515CI-TRIAL-00063515completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
to evaluate the safety and efficacy of Low-dose sirolimus in Kaposiform Hemangioendothelioma in Chinese children by a prospective, randomized open trial.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hemangioma | Hemangioma | ONTOLOGY_EXACT | 0.98 |
| Kaposiform Hemangioendothelioma | Kaposiform Hemangioendothelioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- high blood concentration group
- description
- The blood concentration is maintained at 10-15ng/ml (not including 10ng/ml).
- interventionNames
- Drug: Sirolimus(0.8mg/m2)
- type
- EXPERIMENTAL
- label
- low blood concentration group
- description
- The blood concentration is maintained at 7-10ng/ml (including 10ng/ml).
- interventionNames
- Drug: Sirolimus(0.7mg/m2)
Primary outcomes (1)
- measure
- response to treatment
- timeFrame
- 1 year after taking the drug
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Kaposiform Hemangioendotheliomas with or without Kasabach-Merritt Phenomenon. * 0 - 12 years of age at the time of study entry. * Male or female. * Consent of parents (or the person having parental authority in families): Signed and dated written informed consent. Exclusion Criteria: * with hematological diseases. * with other solid tumors. * with hypertension, diabetes, adrenal insufficiency, neurological diseases, liver and kidney dysfunction, and cardiopulmonary insufficiency. * with tuberculosis,cytomegalovirus and Epstein-Barr virus infection before the treatment.
References
Publications (4)
- BACKGROUNDDrolet BA, Trenor CC 3rd, Brandao LR, Chiu YE, Chun RH, Dasgupta R, Garzon MC, Hammill AM, Johnson CM, Tlougan B, Blei F, David M, Elluru R, Frieden IJ, Friedlander SF, Iacobas I, Jensen JN, King DM, Lee MT, Nelson S, Patel M, Pope E, Powell J, Seefeldt M, Siegel DH, Kelly M, Adams DM. Consensus-derived practice standards plan for complicated Kaposiform hemangioendothelioma. J Pediatr. 2013 Jul;163(1):285-91. doi: 10.1016/j.jpeds.2013.03.080. No abstract available. PMID 23796341
- BACKGROUNDYoon HY, Hwang JJ, Kim DS, Song JW. Efficacy and safety of low-dose Sirolimus in Lymphangioleiomyomatosis. Orphanet J Rare Dis. 2018 Nov 14;13(1):204. doi: 10.1186/s13023-018-0946-8. PMID 30428897
- BACKGROUNDKazmierczak D, Maliszewska A. [Disturbances of tooth and maxillary development in Down's syndrome and their treatment]. Czas Stomatol. 1986 Nov;39(11):755-9. No abstract available. Polish. PMID 2958244
- BACKGROUNDOzgonenel B, Martin A. Low-dose sirolimus controls recurrent iron deficiency in a patient with blue rubber bleb nevus syndrome. Pediatr Blood Cancer. 2015 Nov;62(11):2054-5. doi: 10.1002/pbc.25590. Epub 2015 Jul 1. No abstract available. PMID 26132912