drugset / Trial / 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.

NCT05027386

Phase 1/2 Recruiting 125 enrolled Sun Yat-sen University
Non-randomizedSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2021-08-26
Primary completion
2026-02-04
Completion
2026-02-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Rivoceranib Small molecule Oral
Background Irinotecan Small molecule 50 mg/m2 Intravenous
Background Temozolomide Small molecule 100 mg/m2 Intravenous

Indications