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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-03

Study Completion Date

2023-12-08

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Diffuse Intrinsic Pontine Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

Nimotuzumab+CRT(concurrent IMRT and TMZ)

Group Type EXPERIMENTAL

Nimotuzumab+CRT(concurrent IMRT and TMZ)

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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h-R3

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No