Phase 2 Study of Apatinib with Temozolomide and Etoposide Capsules for Treating Recurrent Medulloblastoma in Children and Young Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining apatinib with temozolomide and oral etoposide for treating children with recurrent medulloblastoma, a type of brain tumor. This phase 2 clinical study is conducted following Good Clinical Practice principles at Beijing Sanbo Brain Hospital. The goal is to observe how well this treatment works and assess its safety in children whose tumors have returned. Participants receive oral apatinib mesylate tablets at a dose of 250 mg daily, taken with warm water about half an hour after a meal. Each treatment cycle lasts 28 days, continuing until the tumor progresses, unacceptable side effects occur, or the participant chooses to withdraw, with a maximum treatment duration of 12 cycles. After 12 cycles, further treatment decisions are made by the investigator. During the study, researchers will monitor tumor response and survival outcomes using imaging studies, with treatment lasting up to two years or until progression or death. They will assess objective response rate, progression-free survival, and overall survival for up to four years. Participants will undergo regular safety and effectiveness evaluations, including imaging scans and clinical assessments, to track treatment effects and side effects throughout the study period.

Apatinib Combined with Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children