OncoMatch/Clinical Trials/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
Is NCT05457829 recruiting? Yes, currently enrolling (May 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 first relapsed and refractory pediatric rhabdomyosarcoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Rhabdomyosarcoma
Prior therapy
Must have received: first-line treatment
Patients who have progressed, relapsed or refractory after first-line treatment (failed to achieve complete or partial response after recent treatment)
Cannot have received: irinotecan combined with temozolomide and vincristine (irinotecan, temozolomide, vincristine)
Patients who had previously received irinotecan combined with temozolomide and vincristine
Cannot have received: irinotecan (irinotecan)
patients who had progressed after treatment with irinotecan
Cannot have received: temozolomide (temozolomide)
patients who had progressed after treatment with ... temozolomide
Cannot have received: doxorubicin hydrochloride liposome (doxorubicin hydrochloride liposome)
patients who had previously received doxorubicin hydrochloride liposome injection chemotherapy
Cannot have received: doxorubicin (doxorubicin)
Patients who had used doxorubicin at a cumulative dose of ≥450 mg/m2
Cannot have received: epirubicin (epirubicin)
epirubicin at a cumulative dose of ≥ 550 mg/m2
Cannot have received: anthracycline
had used anthracyclines in the past to induce heart disease
Lab requirements
Blood counts
ANC ≥1.5×10^9/L (if bone marrow invasion, ANC≥1.0×10^9/L); Platelet count ≥75×10^9/L (PLT≥50×10^9/L for bone marrow invasion)
Kidney function
Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 or serum creatinine ≤ 1.5× ULN (Cockcroft-Gault formula)
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% by cardiac COLOR ultrasound; 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 during screening should meet the following conditions: ... Bilirubin ... AST ... ALT ... eGFR ... serum creatinine ... ANC ... Platelet count
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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