Pilot Study of Anlotinib With STUPP Regimen for Patients With Newly Diagnosed Glioblastoma

Inclusion criteria

• Primary, pathologically confirmed glioblastoma, and complete molecular biological marker tests (MGMT, 1p/19q, IDH, TERT, BRAF, p53, EGFR);
• 2 ~ 6 weeks after operation; the surgical incision healed well;
• Presence of lesions evaluable according to Rano criteria;
• Aged 18-70 years;
• Karnofsky performance status (KPS) ≥ 60;
• The dose of corticosteroid therapy was stable or gradually reduced in the past 5 days;
• No previous radiotherapy, chemotherapy, immunotherapy, or biologic therapy;
• Serum hemoglobin ≥ 100 g/L, platelet count ≥ 80 × 109/L, neutrophil count ≥ 1.5 × 109/L;
• Serum creatinine ≤ 1.25 × ULN or creatinine clearance ≥ 60 mL/min;
• Serum bilirubin ≤ 1.5 × ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN, alkaline phosphatase ≤ 5 × ULN;
• Normal coagulation function (PT prolongation does not exceed 3s, APTT prolongation does not exceed 10s);
• Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use an appropriate method of contraception during the trial and 8 days after administration of the trial drug. Males must agree to use an appropriate method of contraception or be surgically sterile during the trial and after 8 weeks of trial drug administration;
• Patient is sufficiently compliant with study and follow-up procedures;
• Patients signed a formal informed consent form to indicate that they understood that the study was in accordance with hospital policy and ethical requirements.

Exclusion criteria

• Secondary glioblastoma;
• Patients with any other malignant tumor before or now, except skin non-melanotic carcinoma or cervical carcinoma in situ;
• Any other diseases or conditions are contraindications to chemoradiotherapy (such as active phase of infection, within 6 months after cerebral myocardial infarction, symptomatic heart disease including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy);
• Pregnant or lactating women;
• Women and men who are likely to become pregnant but are unwilling to take appropriate contraceptive measures;
• Evidence of hereditary bleeding constitution or coagulation disorders;
• Patients requiring anticoagulant therapy due to other diseases;