Nimotuzumab Combined With the Stupp Regimen for Postoperative Residual Glioblastoma

A Single-arm, Phase II Study of Nimotuzumab Combined With the Stupp Regimen for Postoperative Residual Glioblastoma

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.

This is a prospective, single-arm study designed to enroll 50 adult patients with a confirmed diagnosis of EGFR-positive high-grade glioma and radiographic residual tumor following surgical resection (primary inclusion criteria). Patients are excluded if they are EGFR-negative; have previously received chemotherapy, anti-EGFR therapy, or radiotherapy; have a history of other malignancies within the past 5 years; present with severe comorbidities or active infections; or experience persistent vomiting that may interfere with the oral administration of temozolomide (TMZ). Following surgery, participants will receive nimotuzumab in combination with the standard Stupp regimen.

Inclusion Criteria:

• 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.
• 5）Karnofsky Performance Status (KPS) score ≥ 50% (with KPS decline attributable to the tumor).
• 6）Adequate renal function, defined as serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance > 60 mL/min.
• 7）Adequate hepatic function, defined as total bilirubin ≤ 1.5 times the ULN and serum transaminases ≤ 3 times the ULN.
• 8）Adequate hematologic function, defined as a white blood cell count ≥ 3,000/μL or an absolute neutrophil count (ANC) ≥ 1,500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 10 g/dL.
• 9）An interval of 2 to 6 weeks between surgical resection and the initiation of radiotherapy (RT).

Exclusion Criteria:

• 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).