drugset / Trial / NCT07137884
Anlotinib Hydrochloride Capsules in Maintenance Treatment for Intermediate-High Risk Rhabdomyosarcoma in Children
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |