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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
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
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, China
RECRUITINGXiangya Hospital of Centre-south University
Changsha, Hunan, China
NOT_YET_RECRUITINGWest China Hospital, Sichuan University
Chengdu, Sichuan, China
Objective response rate #ORR# assessed by the Independent Review Committee
Proportion of patients with partial or complete response in tumor burden as defined by RECIST.
Time frame: Up to 12 months
1-year overall survival
The possibility that a patient who has lived for 1 year after treatment will still survive. OS is defined as the time from enrollment to death.
Time frame: Up to 12 months
Progression-free survival#PFS#
PFS is defined as the time from enrollment to disease progression or death from any cause.
Time frame: Up to 12 months
Incidence of adverse events
An adverse event is any adverse event that occurs in a patient or subject of a drug clinical study.
Time frame: Up to 30 days after last administration of Nimotuzumab
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Beijing Tiantan Hospital, Capital Medical University
Beijing, China
RECRUITINGPeking Union Medical College Hospital
Beijing, China
NOT_YET_RECRUITINGXuanwu Hospital Capital Medical University
Beijing, China
RECRUITINGShandong Cancer Hospital
Jinan, China
NOT_YET_RECRUITINGXinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
Shanghai, China
RECRUITING