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Efficacy and Safety of Sirolimus Combined with Interventional Therapy for Refractory Slow-Flow Vascular Malformations in Children

Efficacy and Safety of Sirolimus Combined with Interventional Therapy for Refractory Slow-Flow Vascular Malformations in Children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117580
Enrollment
Unknown
Registered
2026-01-26
Start date
2026-01-26
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

slow-flow vascular malformation

Interventions

Combination Therapy Group:Sirolimus
Standard Intervention Group:Interventional therapy

Sponsors

Jinan Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1.Age 0 to 18 years, no gender restrictions; 2.Confirmed diagnosis of low-flow vascular malformation; 3.No systemic treatment for this lesion within the past six months; 4.Planned to undergo two standardized interventional procedures at this center within six months, with efficacy assessed as “ineffective” (lesion reduction <25%); 5.Guardian signed informed consent form with good compliance.

Exclusion criteria

Exclusion criteria: 1.Patients with a confirmed diagnosis of other vascular malformations such as arteriovenous malformations or Parkes-Weber syndrome; 2.Allergic reactions to interventional therapy-related medications (e.g., piperacillin, iodinated contrast agents); 3.Received other treatments within one month prior to enrollment; 4.Concurrent severe cardiac, pulmonary, hepatic, renal, or hematologic disorders rendering treatment intolerable; 5.Currently receiving immunosuppressive therapy or other medications that may interfere with efficacy assessment; 6.Guardians anticipated to have difficulty completing follow-up or demonstrate poor compliance.

Design outcomes

Primary

MeasureTime frame
Clinical response rate;

Secondary

MeasureTime frame
Early efficacy;

Countries

China

Contacts

Public ContactLiang Wang

Jinan Children's Hospital

1037683769@qq.com+86 531 59616909

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026