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

Biotech Pharmaceutical Co., Ltd.8 sites in 1 country48 target enrollmentApril 3, 2021

ConditionsDiffuse Intrinsic Pontine Glioma

InterventionsNimotuzumab+CRT(concurrent IMRT and TMZ)

DrugsNimotuzumab+CRT(concurrent IMRT and TMZ)

Overview

Phase: Phase 3
Intervention: Nimotuzumab+CRT(concurrent IMRT and TMZ)
Conditions: Diffuse Intrinsic Pontine Glioma
Sponsor: Biotech Pharmaceutical Co., Ltd.
Enrollment: 48
Locations: 8
Primary Endpoint: Objective response rate #ORR# assessed by the Independent Review Committee
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Detailed 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.

Registry

clinicaltrials.gov

Start Date

April 3, 2021

End Date

December 8, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biotech Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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;

Arms & Interventions

Experimental

Nimotuzumab+CRT(concurrent IMRT and TMZ)

Intervention: Nimotuzumab+CRT(concurrent IMRT and TMZ)

Outcomes

Primary Outcomes

Objective response rate #ORR# assessed by the Independent Review Committee

Time Frame: Up to 12 months

Proportion of patients with partial or complete response in tumor burden as defined by RECIST.

Secondary Outcomes

Progression-free survival#PFS#(Up to 12 months)
1-year overall survival(Up to 12 months)
Incidence of adverse events(Up to 30 days after last administration of Nimotuzumab)