UnknownPhase 2

Different Doses of Sirolimus for the Maintenance Treatment of Kaposiform Hemangioendothelioma

China30 participantsStarted 2022-04-05

Plain-language summary

The purpose of this study is to compare the efficacy and safety of different doses of sirolimus in the maintenance treatment of kaposiform hemangioendothelioma.

Who can participate

Age range14 Years

SexALL

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Inclusion criteria

✓. Male and female;
✓. Between 0 and 14 years of age;
✓. Diagnosis of KHE as determined by:
✓. Patients were required to have adequate liver, renal and bone marrow function, and absence of active infection
✓. Consent of parents (or the person with parental authority in families): signed and dated written informed consent.

Exclusion criteria

✕. Patients contraindicated for the administration of sirolimus (e.g., those with an allergy to sirolimus or other rapamycin analog)
✕. Exposure to chemotherapy, embolization, corticosteroids, propranolol, sclerotherapy or any other investigational agents within 1 weeks before enrolment on study;
✕. Patients had a history of a major surgery within 2 weeks before enrollment;
✕. Patients who have a history of treatment with sirolimus or other mTOR inhibitor;
✕. Any known evidence of significant local or systemic uncontrolled infection, defined as receiving intravenous antibiotics at the time of enrollment;
✕. Concurrent severe and/or uncontrolled medical diseases that could compromise participation in the study (e.g. uncontrolled diabetes, uncontrolled hypertension, severe malnutrition, chronic liver or renal disease, active upper gastrointestinal tract ulceration).
✕. Impairment of gastrointestinal function or chronic gastrointestinal disease that may significantly alter the absorption of sirolimus.
✕. Patients with inadequate liver function:

What they're measuring

The changes in KHE volume

Timeframe: 12 months.

Trial details

NCT IDNCT05324384

SponsorWest China Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

Contact for this trial

Yi Ji, MD, PhD

86 28 85423453 jijiyuanyuan@163.com

View on ClinicalTrials.gov More Hemangioendothelioma trials