Health TrialsbyHealthPanel

Sirolimus Discontinuation Strategies in Kaposiform Hemangioendothelioma

ConditionKaposiform Hemangioendothelioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorWest China Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sirolimus

    Drug

    Comparison of different sirolimus discontinuation strategies.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Direct discontinuation groupPlacebo comparator 1 intervention
Group B: Intermittent treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rebound growth rate of KHE

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

Time frame
12 months

Secondary outcomes

1

Incidence of disease sequelae

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.

Time frame
12 months
2

Incidence of adverse events throughout the study.

Incidence of adverse events during the follow-up period.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now