Study of Recombinant Human Endostatin Combined With CV Regimen in the Treatment of Pediatric Low-grade Gliomas
Status:
Recruiting
Trial end date:
2025-10-31
Target enrollment:
Participant gender:
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.