Nimotuzumab in Combined With Concurrent Radiochemotherapy in the Treatment of Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) in Children

  • STATUS
    Recruiting
  • End date
    Dec 8, 2022
  • participants needed
    48
  • sponsor
    Biotech Pharmaceutical Co., Ltd.
Updated on 30 April 2021

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).

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.

Details
Condition Diffuse Intrinsic Pontine Glioma, DIPG
Treatment Nimotuzumab+CRT(concurrent IMRT and TMZ)
Clinical Study IdentifierNCT04532229
SponsorBiotech Pharmaceutical Co., Ltd.
Last Modified on30 April 2021

Eligibility

Yes No Not Sure

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
^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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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