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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
trial testing temozolomide/anlotinib/pembrolizumab in Maintenance Treatment of Diffuse Midline Gliomas in Children in 33 participants. Not yet recruiting.
10 April 2030
Quick facts
| Lead sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 33 |
| Start date | 10 July 2025 |
| Primary completion | 10 April 2030 |
| Estimated completion | 30 July 2030 |
| Sites | 1 location across China |
Drugs / interventions tested
- temozolomide/anlotinib/pembrolizumab — full drug profile →
Conditions studied
- Maintenance Treatment of Diffuse Midline Gliomas in Children — all drugs for Maintenance Treatment of Diffuse Midline Gliomas in Children →
Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Who can join
Adults 3 to 18, any sex, with Maintenance Treatment of Diffuse Midline Gliomas in Children. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07020052
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07020052 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Last refreshed: 8 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07020052.
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