Sirolimus Discontinuation Strategies in Kaposiform Hemangioendothelioma
NCT ID: NCT07131644
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2025-09-13
2028-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Direct discontinuation group
Sirolimus was gradually tapered and discontinued over a 2-month period.
Sirolimus
Comparison of different sirolimus discontinuation strategies.
Low-dose treatment group
Low-dose sirolimus treatment was administered for 6 months (with blood levels maintained at 2-5 ng/mL), followed by gradual tapering and discontinuation over 2 months.
Sirolimus
Comparison of different sirolimus discontinuation strategies.
Intermittent treatment group
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.
Sirolimus
Comparison of different sirolimus discontinuation strategies.
Interventions
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Sirolimus
Comparison of different sirolimus discontinuation strategies.
Eligibility Criteria
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Inclusion Criteria
* With evaluable clinical or imaging parameters to monitor disease activity or recurrence.
* Patients or their guardians are able to understand the study and provide written informed consent.
* Hematologic and hepatic/renal function meet the safety criteria for drug administration.
Exclusion Criteria
ALL
No
Sponsors
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West China Hospital
OTHER
Responsible Party
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Yi Ji
MD, PhD
Principal Investigators
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Yi Ji, PhD
Role: PRINCIPAL_INVESTIGATOR
Sichuan University West China Hospital
Locations
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West China Hospital of Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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References
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Zhou J, Lan Y, Qiu T, Zhang Z, Gong X, Zhang X, Yang C, Zhou Z, Zhang Y, Yang M, Fu J, He C, Peng Q, Hu F, Xia C, Kong F, Chen S, Ji Y. Efficacy and safety of high-vs low-dose sirolimus in patients with kaposiform hemangioendothelioma: A randomized clinical trial. J Am Acad Dermatol. 2025 Jul;93(1):124-131. doi: 10.1016/j.jaad.2025.03.023. Epub 2025 Mar 17.
Zhou J, Li Y, Qiu T, Gong X, Yang K, Zhang X, Zhang Z, Lan Y, Hu F, Peng Q, Zhang Y, Kong F, Chen S, Ji Y. Long-term outcomes of sirolimus treatment for kaposiform hemangioendothelioma: Continuing successes and ongoing challenges. Int J Cancer. 2023 Aug 1;153(3):600-608. doi: 10.1002/ijc.34509. Epub 2023 Mar 22.
Ji Y, Chen S, Zhou J, Yang K, Zhang X, Xiang B, Qiu T, Gong X, Zhang Z, Lan Y, Hu F, Kong F, Qiu Q, Zhang Y. Sirolimus plus prednisolone vs sirolimus monotherapy for kaposiform hemangioendothelioma: a randomized clinical trial. Blood. 2022 Mar 17;139(11):1619-1630. doi: 10.1182/blood.2021014027.
Zhou J, Yang K, Dai S, Qiu T, Zhang X, Gong X, Chen S, Ji Y. Clinical features and management of kaposiform hemangioendothelioma and tufted angioma: Similarities and differences. J Am Acad Dermatol. 2022 Jul;87(1):172-174. doi: 10.1016/j.jaad.2021.07.012. Epub 2021 Jul 14. No abstract available.
Zhou J, Qiu T, Zhang Z, Lan Y, Huo R, Xiang B, Chen S, Qiu L, Xia C, Xu X, Li J, Ma Y, Yao W, Wang Z, Dong C, Qin Z, Tai M, Guo L, He X, Gu S, Li L, Hou F, Cai Y, Wang H, Wang J, Jiang X, Zheng J, Li K, Ji Y. Consensus statement for the diagnosis, treatment, and prognosis of kaposiform hemangioendothelioma. Int J Cancer. 2025 May 15;156(10):1986-1994. doi: 10.1002/ijc.35344. Epub 2025 Jan 20.
Other Identifiers
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20250611
Identifier Type: -
Identifier Source: org_study_id
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