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

Phase 3

Recruiting

• Conditions: Diffuse Intrinsic Pontine Glioma
• Interventions: Drug: Nimotuzumab+CRT(concurrent IMRT and TMZ)

• Registration Number: NCT04532229
• Lead Sponsor: Biotech Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-31
• Study Start: 2021-04-03
• Status Verified: 2023-02
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-27
• Primary Completion: 2023-10-08
• Study Completion: 2023-12-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Nimotuzumab+CRT(concurrent IMRT and TMZ)	Nimotuzumab+CRT(concurrent IMRT and TMZ)

Primary Outcome Measures

Name	Time	Method
Objective response rate #ORR# assessed by the Independent Review Committee	Up to 12 months	Proportion of patients with partial or complete response in tumor burden as defined by RECIST.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival#PFS#	Up to 12 months	PFS is defined as the time from enrollment to disease progression or death from any cause.
1-year overall survival	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.
Incidence of adverse events	Up to 30 days after last administration of Nimotuzumab	An adverse event is any adverse event that occurs in a patient or subject of a drug clinical study.

Trial Locations

Locations (8)

Shandong Cancer Hospital; 🇨🇳 Jinan, China

The Third People's Hospital of Zhengzhou; 🇨🇳 Zhengzhou, Henan, China

Xiangya Hospital of Centre-south University; 🇨🇳 Changsha, Hunan, China

Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine; 🇨🇳 Shanghai, China

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China