125
Participants
Start Date
August 26, 2021
Primary Completion Date
December 26, 2025
Study Completion Date
December 30, 2025
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."
RECRUITING
Yizhuo Zhang, Guangzhou
Sun Yat-sen University
OTHER