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

Phase 3
Recruiting
Research Sponsored by Biotech Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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).

Eligible Conditions
  • Brain Tumor
  • Diffuse Intrinsic Pontine Glioma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate #ORR# assessed by the Independent Review Committee
Secondary study objectives
1-year overall survival
Incidence of adverse events
Progression-free survival#PFS#

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment1 Intervention
Nimotuzumab+CRT(concurrent IMRT and TMZ)

Find a Location

Who is running the clinical trial?

Biotech Pharmaceutical Co., Ltd.Lead Sponsor
30 Previous Clinical Trials
7,558 Total Patients Enrolled
Xiaojun YuanStudy ChairXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Xiaoguang QiuStudy ChairBeijing Tiantan Hospital
1 Previous Clinical Trials
84 Total Patients Enrolled
~10 spots leftby Dec 2025
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