Spots Global Cancer Trial Database for Doxorubicin Hydrochloride Liposome Combined With Irinotecan Versus VIT Regimen in the Treatment of Pediatric Rhabdomyosarcoma

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Trial Identification

Brief Title: Doxorubicin Hydrochloride Liposome Combined With Irinotecan Versus VIT Regimen in the Treatment of Pediatric Rhabdomyosarcoma

Official Title: 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, Phase II Clinical Study

Study ID: NCT05457829

Conditions

Rhabdomyosarcoma, Child

Interventions

Doxorubicin Hydrochloride Liposome+Irinotecan

Temozolomide+Irinotecan+Vincristine

Study Description

Brief 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.