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
| NCT ID | NCT05457829 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-sen University |
| Condition | Rhabdomyosarcoma, Child |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2023-12-30 |
| Primary Completion | 2026-06-30 |
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
Inclusion Criteria 1. 6 months ≤age≤18 years, no gender limitation; 2. The Karnofsky (≥16 years old) or Lansky (\< 16 years old) physical status score is at least 50; 3. The expected survival time is not less than 12 weeks; 4. Heart function: A) Cardiac COLOR ultrasound detection LVEF≥ 50%; B) EKG suggests no myocardial ischemia;C) No history of arrhythmia requiring drug intervention before enrollment; 5. Patients who meet the clinical diagnostic criteria and are diagnosed with pediatric rhabdomyosarcoma; 6. Patients who have progressed, relapsed or refractory after first-line treatment (failed to achieve complete or partial response after recent treatment); 7. Measurable lesions (according to RECIST 1.1 standards, CT scan length of tumor lesions ≥10mm, CT scan short diameter of lymph node lesions ≥15mm, measurable lesions have not received radiotherapy, freezing and other local treatments); 8. The patient must fully recover from the acute toxic effects of all previous anticancer chemo