NCT04532229

Nimotuzumab in Combined With Chemoradiotherapy to Treat the Newly Diagnosed Diffuse Intrinsic Pontine Glioma in Children

A Multicenter, Prospective, Open and Single Arm Clinical Study of Nimotuzumab Combined With Concurrent Radiochemotherapy in the Treatment of Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) in Children

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Biotech Pharmaceutical Co., Ltd. · Academic / Other
• Sex: All
• Age: 3 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-label, single arm, multicenter clinical study. The purpose of the study is to evaluate the clinical efficacy and safety of combination Nimotuzumab with concurrent radiochemotherapy in children with newly diagnosed diffuse intrinsic pontine glioma(DIPG).

Detailed description

This clinical study is designed as a prospective, open-label, single arm, multicenter study to evaluate the clinical efficacy and safety of combination Nimotuzumab with concurrent radiochemotherapy in children with newly diagnosed diffuse intrinsic pontine glioma(DIPG). The main endpoint is objective response rate, 1-year overall survival rate is also observed.

Conditions

• Diffuse Intrinsic Pontine Glioma

Interventions

Type	Name	Description
DRUG	Nimotuzumab+CRT(concurrent IMRT and TMZ)	Drug: Nimotuzumab Concurrent radiochemotherapy period, 150mg/m2, weekly, for 6 weeks; Maintenance period, from the 7th to the 52nd week, 150mg/m2, every two weeks until disease progression or intolerable toxicity. Other Names: h-R3 Drug: Temozolomide Concurrent radiochemotherapy period, 75mg/m2, daily, for 6 weeks; Maintenance period, rest from the 7th to 10th weeks, from the 11th week, 150-200mg/m2, day1 to day5, 21 days for a cycle, for 6 cycles. Other Names: TMZ

Timeline

• Start date: 2021-04-03
• Primary completion: 2023-10-08
• Completion: 2023-12-08
• First posted: 2020-08-31
• Last updated: 2023-07-27

Locations

8 sites across 1 country: China