Glioblastoma
Conditions
Interventions
Experimental group:Anlotinib combined with concurrent radiotherapy and chemotherapy
Sponsors
Affiliated Hospital of Nantong University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Newly treated glioblastoma confirmed by postoperative pathology, and tested for markers (MGMT, 1p/19q, IDH, TERT, BRAF, p53, EGFR); 2. 2-6 weeks after the operation, the incision has healed well; 3. There are lesions that can be evaluated according to the Rano standard; 4. Aged 18-70 years; 5. KPS score >=60; 6. The dose of corticosteroid therapy in the past 5 days is stable or gradually reduced; 7. Have not received any treatment in the past; 8. Serum hemoglobin >=100g/L, platelet >=80x10^9/L, absolute neutrophil count >=1.5x10^9/L; 9. Serum creatinine =60 mL/min; 10. Serum bilirubin <= 1.5 times UNL, AST (SGOT) and ALT (SGPT) <= 2.5 times UNL, alkaline phosphatase <= 5 times UNL; 11. Women of childbearing age must take a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the trial and within 8 weeks after the last administration of the test drug. For men, they must agree to use appropriate methods of contraception or have been surgically sterilized during the trial period and within 8 weeks after the last trial drug administration; 12. Informed consent form signed by the patient.
Exclusion criteria
Exclusion criteria: 1. Have received anti-angiogenic drug treatments such as Anlotinib, Bevacizumab, and Apatinib in the past; 2. Has had other malignant tumors within 5 years or is currently suffering from other malignant tumors at the same time; 3. There is a clear bleeding tendency or bleeding symptoms with significant clinical significance within 28 days before treatment; 4. Imaging within 28 days before treatment showed that the tumor was surrounding important blood vessels, and the investigator determined that entering the study would cause bleeding risk; 5. Those who are allergic to Anlotinib or the drugs involved in this trial; 6. The subjects had any one of the following severe acute comorbidities before randomization: 7. Embolism and bleeding occurred within 4 weeks before enrollment; 8. Severe cardiovascular diseases, including hypertension uncontrollable by medical treatment (BP>= 150/95mm Hg), unstable angina pectoris, history of myocardial infarction in the past 6 months, congestive heart failure> NYHA II, severe arrhythmia and pericardial effusion, etc.; 9. Severe infections require intravenous antibiotics, antifungal or antiviral treatment; 10. Suffer from mental illness and poor compliance; 11. The researcher believes that it is not suitable for inclusion in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactLiu Xiancheng
Affiliated Hospital of Nantong University
Outcome results
None listed