NCT07020052

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 33 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase II single center exploratory clinical trial aimed at evaluating the efficacy and safety of temozolomide combined with anlotinib synchronous radiotherapy sequential triple therapy (temozolomide/anlotinib/PD-L1 inhibitor) for the maintenance treatment of diffuse midline gliomas (DMG) in children. The research plan includes 33 children with DMG aged 3-18 years, who have been pathologically diagnosed and have not received systematic treatment. The implementation will be divided into two stages: synchronous radiotherapy and chemotherapy stage (54Gy radiotherapy+oral temozolomide 75mg/m ²+sequential oral anlotinib) and maintenance treatment stage (increasing temozolomide dose+continuous use of anlotinib+intravenous injection of PD-L1 inhibitor according to body weight). Through multi mechanism synergy (radiotherapy sensitization, anti angiogenesis, and immune activation), the limitations of traditional treatment will be overcome. The primary endpoint is progression free survival (PFS), while secondary endpoints include objective response rate (ORR), 2-year overall survival rate (2y OS), quality of life, and safety (CTCAE 4.0 criteria). The innovation of the research lies in the first proposal of a "synchronous maintenance" staged mode, targeting the molecular characteristics of DMG (H3K27M mutation), combined with previous evidence at home and abroad (such as the median PFS of 10.2 months for anlotinib combined with synchronous radiotherapy), aiming to provide a new comprehensive treatment plan for this highly invasive tumor.

Conditions

• Maintenance Treatment of Diffuse Midline Gliomas in Children

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-10
• Primary completion: 2030-04-10
• Completion: 2030-07-30
• First posted: 2025-06-13
• Last updated: 2025-07-08

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study