OncoMatch/Clinical Trials/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
Is NCT05457829 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Doxorubicin Hydrochloride Liposome+Irinotecan and Temozolomide+Irinotecan+Vincristine for rhabdomyosarcoma, child.
Treatment: Doxorubicin Hydrochloride Liposome+Irinotecan · Temozolomide+Irinotecan+Vincristine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Rhabdomyosarcoma
Demographics
Prior therapy
Cannot have received: irinotecan combined with temozolomide and vincristine
Patients who had previously received irinotecan combined with temozolomide and vincristine
Cannot have received: irinotecan or temozolomide
Patients who had progressed after treatment with irinotecan or temozolomide
Cannot have received: doxorubicin hydrochloride liposome injection chemotherapy
Patients who had previously received doxorubicin hydrochloride liposome injection chemotherapy
Cannot have received: doxorubicin at a cumulative dose of ≥450 mg/m2
Patients who had used doxorubicin at a cumulative dose of ≥450 mg/m2
Cannot have received: epirubicin at a cumulative dose of ≥550 mg/m2
Patients who had used epirubicin at a cumulative dose of ≥ 550 mg/m2
Cannot have received: anthracyclines
Exception: induced heart disease
Patients who had used anthracyclines in the past to induce heart disease
Lab requirements
Blood counts
ANC ≥1.5×10^9/L (ANC≥1.0×10^9/L if bone marrow invasion); Platelet count ≥75×10^9/L (≥50×10^9/L if bone marrow invasion)
Kidney function
Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 or serum creatinine ≤ 1.5× ULN
Liver function
Bilirubin ≤ 2.5× ULN (corresponding to age), AST and ALT ≤ 2.5× ULN (5× ULN if liver metastasis present)
Cardiac function
LVEF ≥ 50%; EKG no myocardial ischemia; no history of arrhythmia requiring drug intervention before enrollment
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; Laboratory tests: ANC, PLT, bilirubin, Cr, AST, ALT
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05457829 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior irinotecan combined with temozolomide and vincristine, irinotecan or temozolomide, doxorubicin hydrochloride liposome injection chemotherapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 18 years or younger and at least 0 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages