Malignant brain stem glioma
Conditions
Interventions
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
3 Years to 21 Years
Inclusion criteria
Inclusion criteria: 1. Subjects volunteered to join the study, sign informed consent, good compliance; 2. Aged 3 (swallowing ability) - 21 years old; 3. Aged > 16 years old, KPS>=50; Aged = 50; 4. If the brain stem glioma is diagnosed as WHO Grade III-IV by pathology or high grade by imaging, it is recommended to have perfect molecular biological markers for examination (IDH,H3K27, TP53, ACVR1, PDGFRA, EGFR, EZHIP,H3G34, TP53, ATRX,PDGFRA, MYCN,NTRK, ALK, ROS, MET ...); 5. In subjects who had undergone surgical biopsy or treatment, the surgical incision healed well; 6. There is at least one measurable lesion according to RANO criteria; 7. The dose of corticosteroid therapy applied for the first 5 days of randomization was stable or gradually reduced; 8. No previous radiotherapy, chemotherapy, immunotherapy or biotherapy; 9. Major organs function well, meeting the following criteria; (1) Blood routine examination criteria should be met (No blood transfusions or blood products were given within 14 days, and no correction was made with G-CSF or other hematopoietic stimulating factors): HB>=90 g/L; ANC>=1.5×10^9/L; PLT>=80×10^9/L; (2) Biochemical tests must meet the following criteria: TBIL 60 ml/min (The Cockcroft-Gault formula); (3) Doppler ultrasound evaluation:Left ventricular ejection fraction (LVEF) >= the lower limit of normal (60%); (4) Coagulation defects:INR.APTT <= 1.5×ULN; (5) Thyroid Function: TSH <= Upper Limit of Normal (ULN), If the abnormal levels of T3 and T4 should be considered, T3 and T4 levels can be included in the group; Or those who do not need drug therapy after consultation with an endocrinologist can be enrolled; (6) Urinary protein < 2+, and 24h urinary protein quantitative display protein must be <= 1g; 10. The parent/guardian of the child or adolescent subject has the ability to understand, agree to, and sign the study informed Consent Form (ICF) and the applicable child consent form before initiating any protocol-related proceedings; Subject has the ability to express consent with parental/guardian consent (where applicable).
Exclusion criteria
Exclusion criteria: 1. WHO Grade I-II glioma or radiographic diagnosis of low-grade brain stem glioma; 2. Supratentorial glioma involves the brain stem; 3. Patients with contraindications for MRI examination (pacemakers, intraocular metal foreign bodies, intracranial metal clips, inremovable hearing AIDS, nerve stimulation electrodes, etc.); 4. Combined disease and history: (1) Present or present with other malignancies within 5 years. The following two conditions can be included: other malignancies treated with a single operation, achieving continuous 5-year disease-free survival; Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basal membrane)]; (2) Subjects with multiple factors affecting oral medication and inability or refusal to place a gastric tube (e.g. intestinal obstruction); (3) Subjects whose adverse events from prior treatment did not recover to = 150mmHg or diastolic >= 100 mmHg); Have grade 2 myocardial ischemia or myocardial infarction, arrhythmia (including QTc >= 450ms(male), QTc >= 470ms(female)), and grade 2 congestive heart failure (NYHA); Active or uncontrolled severe infection (>= CTCAE grade 2 infection); Liver cirrhosis, active hepatitis *; Renal failure requiring hemodialysis or peritoneal dialysis; A history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; Poor diabetes control (fasting blood glucose (FBG) > 10mmol/L); Urine routine indicated urine protein >= ++, and confirmed 24-hour urine protein quantity > 1.0 g; * Note: Active hepatitis (Hepatitis B reference: HBsAg or HBV DNA either positive; Hepatitis C reference: HCV antibody positive, and HCV virus titer test value exceeds the upper limit of normal); 5. Evidence of hereditary bleeding constitution or clotting disorder; Patients who need anticoagulant therapy due to other diseases; 6. Had participated in other anti-tumor drug clinical trials within 4 weeks before enrollment; 7. The patient had dysphagia and was unable to swallow the test drug; 8. Participants who, in the investigator's judgment, have a concomitant medical condition that seriously endangers the safety of the subjects or interferes with the completion of the study, or who are deemed unsuitable for enrollment for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;overall survival;Disease control rate;living quality;security; | — |
Countries
China
Contacts
Public ContactChen Yuanyuan
Sun Yat-sen University Cancer Center
Outcome results
None listed