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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

NCT05457829 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

  • Rhabdomyosarcoma, Child

Interventions

DRUG

Doxorubicin Hydrochloride Liposome+Irinotecan

Q3W, 2 cycles.

DRUG

Temozolomide+Irinotecan+Vincristine

Q3W, 2 cycles.

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yizhuo Zhang, PhD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-30
Primary Completion
2026-06-30
Completion
2026-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05457829 on ClinicalTrials.gov