Nimotuzumab Combined With the Stupp Regimen for Postoperative Residual Glioblastoma

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.

• nimotuzumab (Drug): Nimotuzumab 200 mg will be administered via intravenous infusion once weekly for 6 weeks, followed by 200 mg via intravenous infusion once every 4 weeks for a total of 6 doses.
• Temozolomide (Drug): Temozolomide will be administered orally at a dose of 150-200 mg/m²/day for 5 consecutive days. Each cycle lasts 28 days, for a total of 6 cycles.
• Radiotherapy (Radiation): PTV：60Gy/2Gy/30f，6weeks

Primary outcomes

• Progression-Free Survival [from the initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, up to 100 weeks]: defined as the time from randomization (or the initiation of treatment) to the first documented tumor progression or death from any cause, whichever occurs first

Secondary outcomes

• Overall Survival [from the initiation of treatment，up to 100 weeks]: defined as the time from randomization (or the initiation of treatment) to death from any cause.
• Objective Response Rate [through study completion, an average of 1 year]: defined as the proportion of patients who achieve a Complete Response (CR) or a Partial Response (PR) out of the total number of evaluable patients
• Disease Control Rate [through study completion, an average of 1 year]: defined as the proportion of patients who achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) out of the total number of evaluable patients
• Adverse Event [through study completion, an average of 1 year]: any unfavorable or unintended medical occurrence in a patient or clinical trial subject administered a pharmaceutical product or device, which does not necessarily have a causal relationship with the treatment

Sex: All, ages: 18 Years to 75 Years

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).