Study of Recombinant Human Endostatin Combined With CV Regimen in the Treatment of Pediatric Low-grade Gliomas

This is an interventional treatment trial for Low-grade Glioma Read More

Inclusion Criteria:

1. Age ≥ 3months and ≤18years;
2. Histopathologically confirmed low-grade glioma (WHO grade I and II), including astrocytoma, pilocytic astrocytoma, pleomorphic xanthoastrocytoma, subependymal giant cell astrocytoma, infantile desmoplastic astrocytoma, low-grade oligodendroglioma, oligoastrocytoma, ganglioglioma, and infantile desmoplastic ganglioglioma. Chiasmatic-hypothalamic tumors intrinsic to the optic pathway were eligible without pathologic confirmation.
3. There is a clear evaluable lesion with less than 95% resection or residual tumor of more than 1.5 cm^2；
4. KPS score ≥50 (age> 12 years old) or Lansky score ≥ 50 (age ≤ 12 years old)；
5. Estimated survival of at least 12 weeks;
6. Have not been received radiotherapy or chemotherapy before；

7. Participants must have adequate organ function as defined by the following criteria (within 7 days before treatment):

   Hematology (No transfusion within 14 days):

   Hemoglobin(HB)≥90g/L; Absolute neutrophil count (ANC)≥1.5×10^9/L; Platelet (PLT)≥80×10^9/L.

   Chemistry:

   Serum bilirubin ≤ 1.5×upper limit of normal (ULN) ALT and AST≤2.5ULN； Serum creatinine ≤1.5ULN or creatinine clearance rate(CCr)≥60ml/min； ECG: heart rate in the normal range (55-100beats/min), normal or slightly prolonged QT interval (QTc<480ms), normal or low T wave, normal or non-specific ST segment changes；

8. The patient or his legal guardian signs an informed consent form.

Exclusion Criteria:

1. MRI examination is not available;
2. Diffuse intrinsic pontine glioma or diffuse midline glioma with H3K27 mutation, even though the histopathology is grade I/II;
3. Non-glial low-grade rare intracranial tumors;
4. Receiving any other investigational agent;
5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in this study;
6. Patients who have received organ transplants;
7. Patients with HIV or Treponema pallidum infection;
8. Severe heart disease; ECG shows T wave inversion or elevation or ST segment specific changes;
9. There were clinically significant bleeding symptoms or clear bleeding tendency in the first 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, gastrointestinal perforation, baseline fecal occult blood ++ and above, intracranial or intracranial hemorrhage, or vasculitis;
10. Arteriovenous thrombosis events occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.;
11. Having bleeding disorder and are being treated with thrombolytic or anticoagulant drugs.
12. Patients who are pregnant or breastfeeding.
13. Other conditions considered inappropriate by the researcher for inclusion.