About this trial
This is a prospective, single-arm study. The study population consists of adult patients with a confirmed diagnosis of EGFR-positive high-grade glioma who have radiographic residual tumor following surgical resection. Participants will receive nimotuzumab in combination with the standard Stupp regimen after glioma surgery.
Eligibility criteria
Qualifiers
1)Aged 18 to 75 years.
2)Newly diagnosed glioblastoma consistent with the World Health Organization (WHO) Classification of Tumours of the Central Nervous System, 5th edition.
3)Epidermal growth factor receptor (EGFR)-positive status confirmed by immunohistochemistry (defined as brown-yellow staining in >10% of tumor cells).
4)Partial surgical resection with radiographically measurable residual tumor.
Disqualifiers
1)EGFR-negative status.
2)Prior treatment with chemotherapy, anti-EGFR therapy, or radiotherapy; or a history of other malignancies within the past 5 years.
3)Presence of severe comorbidities or active infections, or persistent vomiting that may interfere with the oral administration of temozolomide (TMZ).
Trial design
Treatments tested in this trial
- nimotuzumab
- Temozolomide
- Radiotherapy