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Doxorubicin hydrochloride liposome injection combined with Irinotecan

Temozolomide combined with Irinotecan and Vincristine

Doxorubicin Hydrochloride Liposome+Irinotecan

Temozolomide+Irinotecan+Vincristine

zhang Yizhuo, PhD

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.

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.

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

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

Objective response rate (ORR) after 2 cycles of chemotherapy with AI or VIT regimen, including complete response (CR) and partial response (PR)

Refers to the percentage of patients with confirmed complete response, partial response, and disease stability in patients with evaluable efficacy.

Means from the date of enrollment to the date of first disease progression or death from any cause, whichever comes first. If the subject has no disease progression during the trial period, PFS is defined as the last date until the subject's last confirmed progression-free survival.

Overall survival (OS) was defined from the date of enrollment to the date of death from any cause.

The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Doxorubicin Hydrochloride Liposome Combined With Irinotecan Versus VIT Regimen in the Treatment of Pediatric Rhabdomyosarcoma	NCT05457829	Rhabdomyosarcom...	Doxorubicin Hyd... Temozolomide+Ir...	6 Months - 18 Years	Sun Yat-sen University
Doxorubicin Hydrochloride Liposome Combined With Irinotecan Versus VIT Regimen in the Treatment of Pediatric Rhabdomyosarcoma	NCT05457829	Rhabdomyosarcom...	Doxorubicin Hyd... Temozolomide+Ir...	6 Months - 18 Years	Sun Yat-sen University

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