Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Nimotuzumab+CRT(concurrent IMRT and TMZ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab+CRT(concurrent IMRT and TMZ) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 months |
| Progression-free survival#PFS# |
Not provided
Inclusion Criteria:
Voluntary and sign a consent form;
Age 3-15 years old, gender unlimited;
Histology or imaging diagnosed as diffuse intrinsic pontine glioma, patients haven't received any anti-tumor treatment;
According to the RANO criteria, at least one measurable lesion;
Before enrollment, the results of laboratory examination are in accordance with:
Blood routine test: platelet count ≥ 100 × 10^9/L; absolute neutrophil count ≥ 1.5 × 10^9/L or leukocyte count ≥ 3.0 × 10^9/L; hemoglobin ≥ 90g/L; Blood biochemistry: aspartate aminotransferase#AST# ≤ 3 ×Upper Limit Of Normal#ULN#; alanine aminotransferase#ALT# ≤ 3 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN;
Lansky score ≥ 60;
Expected survival time ≥ 3 months;
Fertile subjects are willing to take contraceptive measures during the study period.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojun Yuan | Contact | 13817266192 | 13651718916@163.com | |
| Xiaoguang Qiu | Contact | 13701009917 | ttyy6611@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaojun Yuan | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Study Chair |
| Xiaoguang Qiu | Beijing Tiantan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third People's Hospital of Zhengzhou | Recruiting | Zhengzhou | Henan | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
PFS is defined as the time from enrollment to disease progression or death from any cause.
| 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. | Up to 30 days after last administration of Nimotuzumab |
| Xiangya Hospital of Centre-south University | Not yet recruiting | Changsha | Hunan | China |
|
| West China Hospital, Sichuan University | Not yet recruiting | Chengdu | Sichuan | China |
|
| Beijing Tiantan Hospital, Capital Medical University | Recruiting | Beijing | China |
|
| Peking Union Medical College Hospital | Not yet recruiting | Beijing | China |
|
| Xuanwu Hospital Capital Medical University | Recruiting | Beijing | China |
|
| Shandong Cancer Hospital | Not yet recruiting | Jinan | China |
|
| Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine | Recruiting | Shanghai | China |
|
| ID | Term |
|---|---|
| D000080443 | Diffuse Intrinsic Pontine Glioma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D020295 | Brain Stem Neoplasms |
| D015192 | Infratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided