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.

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

August 26, 2021

Primary Completion Date

December 26, 2025

Study Completion Date

December 30, 2025

Conditions
Neuroblastoma
Interventions
DRUG

Apatinib, Irinotecan, Temozolomide

"In the Phase I stage, apatinib was administered using a 3+3 dose escalation design with three dose cohorts. The IT regimen was maintained at fixed doses, with patients receiving up to 6 cycles of chemotherapy. The recommended Phase II dose (RP2D) was determined from the Phase I dose-escalation phase.~In the Phase II stage, the study included an apatinib combination therapy phase and an apatinib maintenance therapy phase. During the combination therapy phase, apatinib was administered at the RP2D in combination with the IT regimen (at fixed doses) for up to 6 cycles. In the maintenance therapy phase, apatinib was administered orally as a single agent at the RP2D until disease progression or intolerable toxicity occurred."

Trial Locations (1)

Unknown

RECRUITING

Yizhuo Zhang, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER