Nimotuzumab in Combined With Concurrent Radiochemotherapy in the Treatment of Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) in Children
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04532229 |
Recruitment Status : Unknown
Verified April 2021 by Biotech Pharmaceutical Co., Ltd..
Recruitment status was: Recruiting
First Posted : August 31, 2020
Last Update Posted : April 22, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diffuse Intrinsic Pontine Glioma | Drug: Nimotuzumab+CRT(concurrent IMRT and TMZ) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 48 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | April 3, 2021 |
Estimated Primary Completion Date : | October 8, 2022 |
Estimated Study Completion Date : | December 8, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Experimental
Nimotuzumab+CRT(concurrent IMRT and TMZ)
|
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 |
- Objective response rate #ORR# [ Time Frame: Up to 12 months ]Proportion of patients with partial or complete response in tumor burden as defined by RECIST.
- 1-year overall survival [ Time Frame: Up to 12 months ]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.
- Progression-free survival#PFS# [ Time Frame: Up to 12 months ]
- Incidence of adverse events [ Time Frame: Up to 30 days after last administration of Nimotuzumab ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 3 Years to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- Recurrent DIPG;
- Have received any other anti-tumor treatment for DIPG, including surgical treatment (except biopsy), chemotherapy, radiotherapy, targeted drugs, immunotherapy, etc;
- Uncontrollable infection, epilepsy and / or hypertension and / or hyperglycemia;
- Human immunodeficiency virus #HIV# infection or active hepatitis B infection or hepatitis C infection;
- Active hemorrhage found by CT or MRI before inclusion and / or inability to carry out CT and MRI examination;
- Major operation (except biopsy) were performed within four weeks before inclusion;
- Decompensated heart failure (NYHA grades III and IV), unstable angina, acute myocardial infarction, persistent and clinically significant arrhythmia within three months of inclusion;
- Have other malignant tumor history;
- Known allergy to Nimotuzumab, temozolomide or its analogues or any component of the prescription;
- Unable to tolerate radiotherapy;
- Other reasons that are not suitable to participate in this study according to the researcher's judgment.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04532229
Contact: Xiaojun Yuan | 13817266192 | 13651718916@163.com | |
Contact: Xiaoguang Qiu | 13701009917 | ttyy6611@126.com |
China, Henan | |
The Third People's Hospital of Zhengzhou | Recruiting |
Zhengzhou, Henan, China | |
Contact: Gang Wang 18037791710 z214023wanggang@126.com | |
China, Hunan | |
Xiangya Hospital of Centre-south University | Not yet recruiting |
Changsha, Hunan, China | |
Contact: Liangfang Shen 13975805137 slf1688@sina.com | |
China, Sichuan | |
West China Hospital, Sichuan University | Not yet recruiting |
Chengdu, Sichuan, China | |
Contact: Qing Mao 18980601506 qingmao2000@163.com | |
China | |
Beijing Tiantan Hospital, Capital Medical University | Recruiting |
Beijing, China | |
Contact: Xiaoguang Qiu 13701009917 ttyy6611@126.com | |
Peking Union Medical College Hospital | Not yet recruiting |
Beijing, China | |
Contact: Wenbin Ma 13701364566 MAWB2001@hotmail.com | |
Xuanwu Hospital Capital Medical University | Recruiting |
Beijing, China | |
Contact: Qingtang Lin 15801588169 kingsang2002@hotmail.com | |
Shandong Cancer Hospital | Not yet recruiting |
Jinan, China | |
Contact: Rongjie Tao 13969191909 053113969191909@163.com | |
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine | Recruiting |
Shanghai, China | |
Contact: Xiaojun Yuan |
Study Chair: | Xiaojun Yuan | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | |
Study Chair: | Xiaoguang Qiu | Beijing Tiantan Hospital |
Responsible Party: | Biotech Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT04532229 |
Other Study ID Numbers: |
BPL-Nim-DIPG-1 |
First Posted: | August 31, 2020 Key Record Dates |
Last Update Posted: | April 22, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Nimotuzumab Temozolomide DIPG |
Glioma Diffuse Intrinsic Pontine Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Brain Stem Neoplasms Infratentorial Neoplasms |
Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Nimotuzumab Antineoplastic Agents, Immunological Antineoplastic Agents |