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NCT03188068
Sirolimus Versus Sirolimus Plus Prednisolone for Kaposiform Hemangioendothelioma
Phase 2 trial testing Sirolimus in Kaposiform Hemangioendothelioma in 30 participants. Completed in 31 December 2021.
31 December 2021
Quick facts
| Lead sponsor | West China Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 June 2017 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sirolimus (sirolimus) — full drug profile →
- Prednisolone — full drug profile →
Conditions studied
- Kaposiform Hemangioendothelioma — all drugs for Kaposiform Hemangioendothelioma →
- Kasabach Merritt Phenomenon — all drugs for Kasabach Merritt Phenomenon →
Sponsor
West China Hospital
Who can join
Adults 1 Day to 18, any sex, with Kaposiform Hemangioendothelioma or Kasabach Merritt Phenomenon. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Kaposiform hemangioendothelioma (KHE) is a rare vascular neoplasm that occurs predominantly in infancy or early childhood. KHE has a nearly equal sex ratio. The annual incidence of KHE has been estimated at 0.071 per 100,000 children. KHE presents with intermediate-malignant and locally aggressive characteristics but without distant metastases. This pilot trial studies sirolimus versus sirolimus plus pednisolone in treating patients diagnosed with kaposiform hemangioendothelioma (KHE) and Kasabach-Merritt phenomemon (KMP) that cannot be removed by surgery. The purpose of this study is to compare the efficacy and safety of orally administered sirolimus versus sirolimus plus pednisolone in the treatment of KHE associated with KMP.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Kaposiform hemangioendothelioma: current knowledge and future perspectives.
Ji Y, Chen S, Yang K, Xia C, et al · · 2020 · cited 103× · PMID 32014025 · DOI 10.1186/s13023-020-1320-1 -
Sirolimus plus prednisolone vs sirolimus monotherapy for kaposiform hemangioendothelioma: a randomized clinical trial.
Ji Y, Chen S, Zhou J, Yang K, et al · · 2022 · cited 64× · PMID 35030255 · DOI 10.1182/blood.2021014027 -
The role of metabolic ecosystem in cancer progression - metabolic plasticity and mTOR hyperactivity in tumor tissues.
Sebestyén A, Dankó T, Sztankovics D, Moldvai D, et al · · 2021 · cited 35× · PMID 35029792 · DOI 10.1007/s10555-021-10006-2 -
Hypoxia-driven angiogenesis and metabolic reprogramming in vascular tumors.
Liu L, Yu J, Liu Y, Xie L, et al · · 2025 · cited 6× · PMID 40443737 · DOI 10.3389/fcell.2025.1572909 -
mTOR hyperactivity and <i>RICTOR</i> amplification as targets for personalized treatments in malignancies.
Sztankovics D, Moldvai D, Petővári G, Dankó T, et al · · 2024 · cited 4× · PMID 38515456 · DOI 10.3389/pore.2024.1611643
Verify or expand the search:
- PubMed search for NCT03188068
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03188068 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by West China Hospital
- Last refreshed: 21 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03188068.
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