OncoMatch/Clinical Trials/NCT05027386
Apatinib Mesylate Combined With IT Regimen for the Treatment of Recurrent or Refractory Pediatric Neuroblastoma: A Single-arm, Phase I/II，Multi-center, Clinical Study.
Is NCT05027386 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Apatinib, Irinotecan, Temozolomide for neuroblastoma.
Treatment: Apatinib, Irinotecan, Temozolomide — The survival rate of recurrent and refractory pediatric neuroblastoma is low and the prognosis is poor. Apatinib mesylate is a highly selective small-molecule vasoendothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor. Apatinib mesylate has been shown to be safe and effective in recurrent or refractory pediatric neuroblastoma in Sun Yat-sen University Cancer Center. Apatinib mesylate combined with IT regimen is expected to further improve the efficacy and survival rate of recurrent or refractory pediatric neuroblastoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
ANC ≥1.5×10^9/L (if the bone marrow is invaded, then ANC≥1.0×10^9/L); Platelet (PLT) ≥75×10^9/L (if bone marrow invades, then PLT ≥50×10^9/L)
Kidney function
Creatinine ≤ 1.5 times ULN (calculated according to the standard Cockcroft-Gault formula)
Liver function
Bilirubin ≤1.5 times ULN; ALT/AST≤3 times ULN (if there is liver metastasis, it can be relaxed to 5 times ULN)
The absolute value of neutrophils (ANC) ≥1.5×10^9/L (if the bone marrow is invaded, then ANC≥1.0×10^9/L) Platelet (PLT) ≥75×10^9/L (if bone marrow invades, then PLT ≥50×10^9/L) Bilirubin ≤1.5 times ULN Creatinine ≤ 1.5 times ULN (calculated according to the standard Cockcroft-Gault formula) ALT/AST≤3 times ULN (if there is liver metastasis, it can be relaxed to 5 times ULN)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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