Nimotuzumab in Combined With Chemoradiotherapy to Treat the Newly Diagnosed Diffuse Intrinsic Pontine Glioma in Children

Biotech Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Diffuse Intrinsic Pontine Glioma

Treatments: Drug: Nimotuzumab+CRT(concurrent IMRT and TMZ)

Study type: Interventional

Funder types: Other

Identifiers

NCT04532229

BPL-Nim-DIPG-1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 3 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntary and sign a consent form;

2. Age 3-15 years old, gender unlimited;

3. Histology or imaging diagnosed as diffuse intrinsic pontine glioma, patients haven't received any anti-tumor treatment;

4. According to the RANO criteria, at least one measurable lesion;

5. 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;

6. Lansky score ≥ 60;

7. Expected survival time ≥ 3 months;

8. Fertile subjects are willing to take contraceptive measures during the study period.

Exclusion criteria

1. Recurrent DIPG;
2. Have received any other anti-tumor treatment for DIPG, including surgical treatment (except biopsy), chemotherapy, radiotherapy, targeted drugs, immunotherapy, etc;
3. Uncontrollable infection, epilepsy and / or hypertension and / or hyperglycemia;
4. Human immunodeficiency virus #HIV# infection or active hepatitis B infection or hepatitis C infection;
5. Active hemorrhage found by CT or MRI before inclusion and / or inability to carry out CT and MRI examination;
6. Major operation (except biopsy) were performed within four weeks before inclusion;
7. Decompensated heart failure (NYHA grades III and IV), unstable angina, acute myocardial infarction, persistent and clinically significant arrhythmia within three months of inclusion;
8. Have other malignant tumor history;
9. Known allergy to Nimotuzumab, temozolomide or its analogues or any component of the prescription;
10. Unable to tolerate radiotherapy;
11. Other reasons that are not suitable to participate in this study according to the researcher's judgment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Experimental

Experimental group

Description:

Nimotuzumab+CRT(concurrent IMRT and TMZ)

Treatment:

Drug: Nimotuzumab+CRT(concurrent IMRT and TMZ)