diffuse midline gliomas
Conditions
Interventions
Experimental:Anlotinib, Radiation and Temozolomide
Placebo Comparator::Placebo, Radiation and Temozolomide
Sponsors
Tangdu Hospital, Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged from 3 to 70 years old, regardless of gender, and able to cooperate with radiotherapy. 2.According to the WHO classification (2021) standard, it was confirmed by histopathology as: diffuse midline glioma, H3K27 varian. 3.Subjects must be enrolled and begin treatment within 4-6 weeks after surgery. They did not receive glucocorticoid treatment 7 days before enrollment, or the dose of glucocorticoid treatment received 7 days before enrollment was stable or decreased. 4.Lansky (3-15 years old) or KPS (= 16 years old) score = 70 points, can swallow drugs and maintain oral administration. 5.The expected survival period = 3 months. 6.At least 14 days before the start of randomization, the bone marrow, liver, and kidney functions of the subjects should meet the following criteria: a) Absolute neutrophil count (ANC) = 1.5 × 109/L. b) Platelet = 80 × 109/L. c) Hemoglobin (Hgb) = 9.0 g/dL (Note: achieving a level of Hgb = 9.0 g/dL through blood transfusion or other interventions is also acceptable). d) Renal function: The creatinine clearance rate calculated using the Croft Gault formula is = 30ml/min. e) Liver function: Total bilirubin = 1.5 times the standard upper limit (ULN), and glutamic oxaloacetic transaminase (AST) and alanine transaminase (ALT) = 3 times the standard upper limit (ULN). Subjects with Gilbert syndrome recorded in their medical history may also be considered for inclusion if their total bilirubin is less than 3 times the standard upper limit. 7.Within 21 days before randomization, the electrocardiogram (ECG) did not indicate acute myocardial ischemia. 8.Female subjects of reproductive age must be non-lactating and undergo a blood pregnancy test within 7 days before the first administration, and the result is negative, either have undergone surgical sterilization, or their only sexual partner has undergone surgical sterilization, or have been postmenopausal for at least 2 years. In addition, female subjects of reproductive age must commit to using any of the acceptable contraceptive methods listed below throughout the entire study period and within 3 months after receiving the last study treatment, and male subjects should adopt at least one acceptable contraceptive method (i.e., using intrauterine devices, barrier methods containing spermicides, condoms, any form of hormone contraceptives, or abstinence). 9.The subject or his guardian voluntarily participated in the study and signed an informed consent form, being able to understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Those who have received bevacizumab, iodine in vivo radiation, short cycle radiation therapy, PD-1/PD-L1, and other chemical toxicity, targeted, immunotherapy within one month before enrollment, or who plan to receive other treatments, such as electric fields during the trial period. 2. Unable to perform enhanced MRI scanning. 3. Within 6 months before enrollment, there were grade III and IV heart failure (NYHA grade), unstable angina pectoris, acute myocardial infarction, persistent and clinically significant arrhythmia; A history of uncontrollable hypertension, thrombosis, spontaneous hemorrhagic disease, or other previous disease history with abnormal coagulation mechanisms; 4. Serious trauma or infection that has affected current anti-tumor treatment within 4 weeks before enrollment. 5.According to the National Cancer Institute's Common Adverse Reaction Event Evaluation Standard (NCI-CTCAE 5.0), there are chronic toxic reactions (excluding hair loss) of grade 3 or above. 6. Major surgery (excluding glioma surgery) was performed within 4 weeks before enrollment; Those who had undergone bone marrow biopsy, open biopsy, or intracranial biopsy within 7 days before screening; And other patients with high risk factors for bleeding. 7. Anti HIV (+), or both HBsAg and HBV-DNA are (+), or both anti HCV and HCV-RNA are (+); 8. Those who had other malignant tumors within the past 5 years and have not been effectively controlled, except for cervical carcinoma in situ, skin squamous cell carcinoma, or localized basal cell skin cancer. 9. Long-term and sustained use of hematopoietic growth factors (including granulocyte colony stimulating factor, macrophage colony stimulating factor, or interleukin-11) or platelet infusion is required to maintain a platelet count of=80×109/L, absolute neutrophil count=1.5×109/L. 10. Pregnant or lactating women, or those who plan to become pregnant during the period of this study. 11. Those who participated in other clinical trials within 30 days before study enrollment. 12. The investigator determines that it is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Objective Response Rate;Lansky (3-15 years old) or Karnofsky Performance Status (= 16 years old);Quality of Life score (EORTC QLQ-C30 and EORTC QLQ-BN20); | — |
Countries
China
Contacts
Public ContactLiang Wang
Tangdu Hospital, Fourth Military Medical University
Outcome results
None listed