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 (Jun 2026). This Phase 1/2 trial studies Apatinib, Irinotecan, Temozolomide for neuroblastoma.

Phase 1/2RecruitingSun Yat-sen UniversityNCT05027386Data as of Jun 2026Location: China

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.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

Apatinib, Irinotecan, Temozolomide

Cancer type

Neuroblastoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages 5–18

Prior therapy

Min 1 prior line

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.

Frequently asked questions

Is NCT05027386 currently recruiting?

Yes, this trial is currently recruiting patients.

Is there an age limit?

Yes. Patients must be 18 years or younger and at least 5 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.

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Neuroblastoma trials