Nimotuzumab Combined With the Stupp Regimen for Postoperative Residual Glioblastoma
Starting soon · Phase 2
Conditions studied: Glioma, Malignant
In brief
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.
Key facts
- Study ID
- NCT07707973
- Run by
- Tianjin First Central Hospital
- People needed
- 50
- Starts
- 2026-07-03
- Expected to finish
- 2029-06-03
- Last updated by the study team
- 2026-07-16
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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).
Full record on ClinicalTrials.gov
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