NCT05457829

Doxorubicin Hydrochloride Liposome Combined With Irinotecan (AI Regimen) Versus VIT Regimen in the Treatment of First Relapsed and Refractory Pediatric Rhabdomyosarcoma: a Prospective, Open-label, Randomized Controlled, Multicenter, Phase II Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, randomized, controlled, open-label, prospective clinical trial was designed to evaluate the efficacy and safety of doxorubicin hydrochloride liposome injection in combination with irinotican (AI regimen) versus VIT regimen in the treatment of first relapsed and refractory pediatric rhabdomyosarcoma.

Detailed description

The primary objective of this study was to evaluate the objective response rate (ORR) of first relapsed and refractory rhabdomyosarcoma in children after 2 cycles of chemotherapy with AI or VIT regimens. Secondary objectives were to evaluate the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety of AI and VIT regimen in the treatment of relapsed and refractory pediatric rhabdomyosarcoma.

Conditions

• Rhabdomyosarcoma, Child

Interventions

Type	Name	Description
DRUG	Doxorubicin Hydrochloride Liposome+Irinotecan	Q3W, 2 cycles.
DRUG	Temozolomide+Irinotecan+Vincristine	Q3W, 2 cycles.

Timeline

• Start date: 2023-12-30
• Primary completion: 2026-06-30
• Completion: 2026-07-31
• First posted: 2022-07-14
• Last updated: 2025-04-16

Locations

1 site across 1 country: China