Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma

Launched by BIOTECH PHARMACEUTICAL CO., LTD. · Dec 24, 2017

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Eligibility criteria

• Inclusion Criteria:
• • Newly diagnosed, histologically proven single supratentorial GBM (WHO grade 4);
• • EGFR positive;
• • \>50％ of the gross tumor volume removed by surgery；
• • Karnofsky performance score (KPS) ≥ 60;
• • Adequate renal function (creatinine ≤1.5×upper limit of normal \[ULN\] or creatinine clearance ≥ 60 mL/min), hepatic function (total bilirubin ≤1.5×ULN and serum transaminases ≤3×ULN), and hematologic function (white blood cell count ≥ 3,000/uL or absolute neutrophil count ≥ 1,500/uL, platelets ≥ 100,000/uL, and hemoglobin ≥ 10 g/dL).
• • Tumor tissue was required for central pathology review and re-checking EGFR and MGMT expression status;
• • An interval of 2 to 6 weeks between surgery and RT was required.
• Exclusion Criteria:
• • Negative EGFR expression;
• • Prior chemotherapy, anti-EGFR therapy, RT, or a history of malignancy in the previous 5 years;
• • Patients with severe complications or active infection;
• • Continuous vomiting that could interfere with the oral administration of TMZ;
• • Pregnancy