NCT07137884

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

A Phase II, Multicenter, Randomized, Controlled Clinical Study of Anlotinib Hydrochloride Capsules as Maintenance Therapy for Intermediate-High Risk Rhabdomyosarcoma in Children

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Anlotinib Hydrochloride is a novel multi-target tyrosine kinase inhibitor.It can effectively inhibit kinases such as VEGFR, PDGFR, FGFR, c-Kit and Met, and has the functions of anti-tumor angiogenesis and inhibiting tumor growth.Especially for vascular endothelial growth factor receptor 2 (VEGFR2/KDR) and VEGFR3 shows a highly selective inhibitory effect, with a half-maximal inhibitory concentration (IC50) of less than 1.0 nM, which is significant, and has a significant anti-angiogenic effect.

Conditions

• Rhabdomyosarcoma Recurrent
• Maintenance Treatment

Interventions

Type	Name	Description
DRUG	Anlotinib+Cyclophosphamide+Vinorelbine	Anlotinib hydrochloride capsules combined with Cyclophosphamide+Vinorelbine), Anlotinib hydrochloride capsules 8mg (weight ≤35kg) or 12mg (weight \> 35kg), po, qd, D1-D14;on an empty stomach ,Two weeks off for one week，with a cycle of 3 weeks. Cyclophosphamide 25mg/m2, po, qd, D1-D28, with a cycle of 4 weeks. vinorelbine 60g/m2, po, qw, D1, 8,15, with a cycle of 4 weeks.
DRUG	Cyclophosphamide+Vinorelbine	Cyclophosphamide 25mg/m2, po, qd, D1-D28, with a cycle of 4 weeks. vinorelbine 60mg/m2, po, qw, D1, 8,15, with a cycle of 4 weeks.

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-10-30
• Completion: 2028-12-30
• First posted: 2025-08-22
• Last updated: 2025-08-22

Locations

1 site across 1 country: China