Clinical Trial

Anlotinib Hydrochloride Capsules in Maintenance Treatment for Intermediate-High Risk Rhabdomyosarcoma in Children

Study acronym: ALTER-02
Not Yet Recruiting Phase 2
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Summary
This is a randomized controlled phase II clinical study aimed at evaluating the efficacy and safety of anlotinib hydrochloride in children with Intermediate-High -risk rhabdomyosarcoma. The study enrolled children with rhabdomyosarcoma confirmed by histopathology, with a clinical risk classification of high or Intermediate-risk accompanied by high-risk factors (high-risk factors are defined as age \> 10 years,Poor prognosis molecular characteristics or those who cannot undergo surgery/radiotherapy);One year of maintenance treatment with anlotinib can increase the duration of response and long-term survival.
Trial Details
NCT Number NCT07137884
Lead Sponsor Sun Yat-sen University
Conditions Rhabdomyosarcoma Recurrent, Maintenance Treatment
Enrollment 150 participants
Start Date 2025-10-01
Primary Completion 2028-10-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-22