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NCT Number: NCT07131644

Sirolimus Discontinuation Strategies in Kaposiform Hemangioendothelioma

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.

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Key information

Conditions

Kaposiform Hemangioendothelioma

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • KHE patients who have received sirolimus treatment and met the criteria for drug discontinuation.
  • 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

  • Patients who are unable to comply with the follow-up or treatment schedule, potentially affecting the integrity of study data.

Treatment and study plan

sirolimus

Drug

Comparison of different sirolimus discontinuation strategies.

Primary outcomes

  1. Rebound growth rate of KHE

    Time frame: 12 months

    The primary endpoint is the rebound growth rate of KHE during the follow-up period.

Secondary outcomes

  1. Incidence of disease sequelae

    Time frame: 12 months

    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.

  2. Incidence of adverse events throughout the study.

    Time frame: 12 months

    Incidence of adverse events during the follow-up period.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiangyuan Zhou, Doctor

CONTACT

[email protected]

+8613668491160

Yi Ji, PhD

CONTACT

[email protected]

+862885423453

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

A Randomized Controlled Trial Comparing Three Sirolimus Discontinuation Strategies in Patients With Kaposiform Hemangioendothelioma

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 20, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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