drugset / Trial / NCT07137884

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

NCT07137884

Phase 2 Not yet recruiting 150 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-10-01
Primary completion
2028-10-30
Completion
2028-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Catequentinib Small molecule 8 mg Oral
Subject Catequentinib Small molecule 12 mg Oral
Comparator Cyclophosphamide Other / unclassified 25 mg/m2 Oral
Comparator Vinorelbine Small molecule 60 mg/m2 Oral

Indications