Phase II Exploratory Study of Sequential Triple Therapy (Temozolomide/Anlotinib/Bemarituzumab) in Combination With Concurrent Radiotherapy With Temozolomide and Anlotinib for the Maintenance Treatment of Diffuse Midline Gliomas in Children

Not yet recruitingOBSERVATIONAL
Enrollment

33

Participants

Timeline

Start Date

July 10, 2025

Primary Completion Date

April 10, 2030

Study Completion Date

July 30, 2030

Conditions
Maintenance Treatment of Diffuse Midline Gliomas in Children
Interventions
DRUG

temozolomide/anlotinib/pembrolizumab

"Starting from 30 days after radiotherapy, adjuvant temozolomide was orally administered at a dose of 150mg/m2. The dosage of temozolomide was adjusted to 200mg/m2 starting from the second cycle, with continuous use for 5 days per week and a 23 day hiatus. Oral administration for a total of 6 cycles.~The start time of oral administration of anlotinib after radiotherapy follows the cycle of radiotherapy, with continuous oral administration for 2 weeks and cessation for 1 week. Until the side effects are intolerable or the tumor progresses. The maximum duration shall not exceed 24 months.~Begin treatment with bemarituzumab 24 hours after radiotherapy, with a body weight of\>=45kg, intravenous injection of 200mg, once every 3 weeks. Weight\<45kg, 100mg intravenous injection, once every 3 weeks. Until the side effects are intolerable or the tumor progresses. The maximum duration shall not exceed 24 months."

Trial Locations (1)

Unknown

inyinhu Cancer Center, UnionMedical College Affiliated Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

All Listed Sponsors
lead

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER