Study of Recombinant Human Endostatin Combined With CV Regimen in the Treatment of Pediatric Low-grade Gliomas
Condition: Low-grade Glioma; Pediatric Brain Tumor
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 2

Summary: 
      Low-grade gliomas (LGGs) are the most common intracranial tumors in children, accounting for
      about 40% of intracranial tumors in children. The biological characteristics and clinical
      prognosis of LGGs vary greatly, and they can present different biological characteristics
      such as restricted growth, invasive growth, and malignant transformation during their
      development. The prognosis of LGGs is related to the degree of tumor resection, histological
      type, and whether it has spread.

      For LGGs, surgical resection is the main treatment method. However, many tumors located in
      the visual pathway, brainstem, hypothalamus and other midline parts, it is impossible to
      completely remove. Radiotherapy can effectively control tumor progression to a certain
      extent, but radiotherapy can cause obvious and serious delayed damage, such as cognitive
      impairment, endocrine disorders, cerebrovascular events, and second tumors. Chemotherapy can
      effectively treat LGGs in children, and can postpone or avoid radiotherapy. It is the
      preferred treatment for children with LGGs after surgery. Carboplatin combined with
      vincristine, the CV regimen, is currently the main chemotherapy regimen for the treatment of
      children with LGGs.

      Anti-angiogenesis is a new type of treatment. Bevacizumab, a humanized monoclonal antibody
      that targets vascular endothelial growth factor (VEGF). Among children with relapsed,
      refractory or progressing LGGs, the effective rate of Bev combined with irinotecan was 44%,
      and the 6-month and 2-year progression-free survival rates were 85% and 48%, respectively.
      However, almost all of them were treated with Bev progressed again. Tumor growth is more
      aggressive after Bev treatment fails. Recombinant human endostatin (rh-ES) is an endogenous
      broad-spectrum angiogenesis inhibitor that has been shown to significantly improve
      therapeutic efficacy when combining with conventional chemotherapy agents in non-small-cell
      lung cancer, breast cancer and melanoma.Previous retrospective studies of the research team
      found that rh-ES combined with CV can treat LGGs in children effectively, shorten the onset
      time, help quickly alleviate the symptoms of brainstem damage, and improve the quality of
      life.

      This study intends to use prospective clinical studies to further confirm the efficacy and
      safety of the anti-angiogenic drug rh-ES combined with traditional CV regimens in the
      treatment of children with LGGs.
    


Intervention name(s): combined therapy with rh-ES and CV
Intervention type(s): Drug
Intervention description(s): All the patients receive combined therapy with recombinant human endostatin and traditional weekly CV regimen.
Carboplatin is administered at a dose of 220 mg/m2. Vincristine is administered at a dose of 1.5 mg/m2 (maximum dose 2 mg). Recombinant human endostatin (rh-ES) is administrated at a dose of 15mg daily, for 14 consecutive days every 3 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment