Clinical Trial Finder

Inclusion Criteria:

1. Primary, pathologically confirmed glioblastoma, and complete molecular biological marker tests (MGMT, 1p/19q, IDH, TERT, BRAF, p53, EGFR); 2. 2 ~ 6 weeks after operation; the surgical incision healed well; 3. Presence of lesions evaluable according to Rano criteria; 4. Aged 18-70 years; 5. Karnofsky performance status (KPS) ≥ 60; 6. The dose of corticosteroid therapy was stable or gradually reduced in the past 5 days; 7. No previous radiotherapy, chemotherapy, immunotherapy, or biologic therapy; 8. Serum hemoglobin ≥ 100 g/L, platelet count ≥ 80 × 109/L, neutrophil count ≥ 1.5 × 109/L; 9. Serum creatinine ≤ 1.25 × ULN or creatinine clearance ≥ 60 mL/min; 10. Serum bilirubin ≤ 1.5 × ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN, alkaline phosphatase ≤ 5 × ULN; 11. Normal coagulation function (PT prolongation does not exceed 3s, APTT prolongation does not exceed 10s); 12. 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; 13. Patient is sufficiently compliant with study and follow-up procedures; 14. 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:

1. Secondary glioblastoma; 2. Patients with any other malignant tumor before or now, except skin non-melanotic carcinoma or cervical carcinoma in situ; 3. 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); 4. Pregnant or lactating women; 5. Women and men who are likely to become pregnant but are unwilling to take appropriate contraceptive measures; 6. Evidence of hereditary bleeding constitution or coagulation disorders; 7. Patients requiring anticoagulant therapy due to other diseases;

Arms

Experimental: single-arm

single-arm Drug: Anlotinib Drug: Temozolomide Radiotherapy:Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0 Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy.

Interventions

Drug: - Drug is Anlotinib.

Anlotinib 8 mg/day (Chia-tai Tianqing Pharmaceutical Co., Ltd.) was given orally on days 1 to 14 per 3-week cycle for 2 cycles during concomitant therapy and maximally 8 cycles during adjuvant chemotherapy. One week after discontinuation of adjuvant chemotherapy, anlotinib 8 mg/day was given for maintenance .

Drug: - Drug is Temozolomide Capsule.

Temozolomide 75 mg/m2/day was taken for maximally 49 days during concurrent chemoradiotherapy. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients received adjuvant temozolomide for 5 days every 28 days, first cycle 150 mg/m2/day and subsequent cycles 200 mg/m2/day for maximally 6 cycles .

Radiation: - Radiotherapy was initiated 4 to 6 weeks postoperatively.

Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0 Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy.