clinical trial · NCT05457829
Doxorubicin Hydrochloride Liposome Combined With Irinotecan (AI Regimen) Versus VIT Regimen in the Treatment of Relapsed and Refractory Pediatric Rhabdomyosarcoma: a Prospective, Open-label, Randomized Controlled, Multicenter, Phase II Clinical Study
Sun Yat-sen University·phase2·recruiting·n = 88
Rhabdomyosarcoma, ChildDoxorubicin Hydrochloride Liposome+IrinotecanTemozolomide+Irinotecan+Vincristine
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 relapsed and refractory pediatric rhabdomyosarcoma.
started
Dec 30, 2023
primary completion
Jun 30, 2026
completion
Jul 31, 2026
last updated
May 18, 2026
detailed description
The primary objective of this study was to evaluate the objective response rate (ORR) of 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.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol