Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioma

Diffuse Intrinsic Pontine Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Brain Stem Neoplasms

Infratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Nimotuzumab

Temozolomide

Antineoplastic Agents, Immunological

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

Nimotuzumab+CRT(concurrent IMRT and TMZ)

Xiaojun Yuan

Xiaoguang Qiu

Gang Wang

Liangfang Shen

Qing Mao

Wenbin Ma

Qingtang Lin

Rongjie Tao

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.

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

Proportion of patients with partial or complete response in tumor burden as defined by RECIST.

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.

PFS is defined as the time from enrollment to disease progression or death from any cause.

An adverse event is any adverse event that occurs in a patient or subject of a drug clinical study.

Biotech Pharmaceutical Co., Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nimotuzumab in Combined With Chemoradiotherapy to Treat the Newly Diagnosed Diffuse Intrinsic Pontine Glioma in Children	NCT04532229	Diffuse Intrins...	Nimotuzumab+CRT...	3 Years - 15 Years	Biotech Pharmaceutical Co., Ltd.
Nimotuzumab in Combined With Chemoradiotherapy to Treat the Newly Diagnosed Diffuse Intrinsic Pontine Glioma in Children	NCT04532229	Diffuse Intrins...	Nimotuzumab+CRT...	3 Years - 15 Years	Biotech Pharmaceutical Co., Ltd.
Nimotuzumab in Combined With Chemoradiotherapy to Treat the Newly Diagnosed Diffuse Intrinsic Pontine Glioma in Children	NCT04532229	Diffuse Intrins...	Nimotuzumab+CRT...	3 Years - 15 Years	Biotech Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for nimotuzumab+crt(concurrent imrt and tmz)