Glioma
Conditions
Interventions
experimental group:Anlotinib combined with Temozolomide
Anlotinib: 10–12 mg/day orally on days 1–14, followed by a 7?day rest (days 15–21), with a 3?week cycle.
Temozolomide: administered according to
control group:Bevacizumab plus Temozolomide
Bevacizumab: 10 mg/kg administered intravenously on days 1 and 15, with a 4?week cycle.
Temozolomide: same regimen as the experimental group.
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years, no restriction on gender. Females of childbearing potential must use adequate contraceptive methods throughout the study period. 2. Patients with recurrent or progressive high-grade glioma (WHO Grade 3 and 4) for the first time after standard treatments including surgery, radiotherapy and/or chemotherapy, confirmed by histopathology or cytology. At least one evaluable lesion must be identified on contrast-enhanced brain MRI. 3. Baseline Karnofsky Performance Status (KPS) score >= 60 prior to treatment initiation. 4. Toxicities from prior anti-tumor therapies must recover to Grade 1 or lower per CTCAE Version 5.0 (alopecia excluded). For patients receiving corticosteroids, the dosage must remain stable or be tapered for a minimum of 3 days prior to baseline imaging assessment. 5. Laboratory test results shall meet the following criteria: (1) Hematology: White blood cell (WBC) >= 3.0×10?/L; Red blood cell (RBC) >= 4.0×10?/L; Hemoglobin (HGB) >=100 g/L; Platelet (PLT) >= 100×10?/L. (2) Hepatic and renal function: Total bilirubin (TBIL) = 30 mL/min; Urine protein <2+. (3) Coagulation function: Activated partial thromboplastin time (APTT) <1.5×ULN; International normalized ratio (INR) <1.5×ULN. 6. Able to understand and willing to sign written informed consent, agree to receive at least one cycle of treatment with anlotinib plus temozolomide or bevacizumab plus temozolomide, and comply with the study protocol regarding treatment administration, scheduled visits and all other study-related procedures.
Exclusion criteria
Exclusion criteria: 1.Patients with hypersensitivity to any component of the study drugs. 2. Patients previously treated with anlotinib, bevacizumab, other VEGF inhibitors, or VEGF receptor signaling inhibitors. 3. Patients participating in another clinical trial that has not been completed. 4. Patients with bleeding risk or coagulation disorders, evidence of recent hemorrhage on brain MRI, a medical history of stroke or transient ischemic attack (TIA) within 6 months prior to enrollment; patients who underwent invasive surgery within 4 weeks before randomization, or have unhealed wounds, active skin ulcers, or incompletely healed fractures. 5. Patients with severe complications and/or underlying diseases, including but not limited to myocardial infarction, unstable angina, uncontrolled hypertension, gastrointestinal hemorrhage, hepatic and renal dysfunction, intractable active infection, or other malignant tumors; or any other concomitant disease that, in the investigator’s judgment, seriously endangers patient safety or impairs trial completion. 6. Pregnant or breastfeeding women. 7. Patients with an estimated survival time of less than 3 months at pre-enrollment assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;6-month progression-free survival rate;Tumor response;Quality of life; | — |
Countries
China
Contacts
Public ContactLi Fei
The First Affiliated Hospital of Army Medical University
Outcome results
None listed