Glioblastoma
Conditions
Interventions
Control group:Temozolomide capsules are 150mg/m2 in the first cycle and 200mg/m2 from the second cycle, once a day, administered on the 1st~5th day, with a 23-day break, every 28 days as a cycle, a to
The dose can be adjusted as tolerated.
Experimental group:Enteric-coated capsule of braitinib 300mg/time, twice daily, orally, 28 days as a cycle, continuous administration for a total of 6 cycles
The dose can be adjusted as tolerated. Temozolomide capsules are 150mg/m2 in the first cycle and 200mg/m2 from the second cycle, once a day, continuously administered on the 1st~5th day, with a 23-day
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must meet the following criteria to be enrolled in the study: 1. 18=50); 4. The operation time is within 3 months, and the concurrent chemoradiotherapy treatment should be completed with full dose and full course of treatment: local conventional fractionated radiotherapy (total dose 54~60Gy, 1.8~2.0Gy/time) and temozolomide concurrent chemotherapy (75mg/m2/day, starting from the first radiotherapy, continuous administration for 6 weeks); 5. After the end of concurrent chemoradiotherapy, there was no tumor progression during the 4-week interval; 6. Have not received any other postoperative treatment except concurrent chemoradiotherapy; 7. No glucocorticoid therapy 5 days prior to enrollment; 8. The results of laboratory tests before enrollment are consistent with: 1) Routine blood count: platelet count>=75×109/L; Absolute neutrophil count>=1.5×109/L; Hemoglobin > 90g/L; 2) Blood biochemistry: aspartate aminotransferase (AST, SGOT) = 60 points, can swallow the drug and remain orally administered; 10. Expected survival >=6 months; 11. Females of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose and commit to using at least one acceptable form of contraception (i.e., intrauterine device, barrier method with spermicide, condom, any form of hormonal contraceptive, or abstinence) throughout the study and for 3 months after the last dose of study treatment; 12. Voluntarily participate in this study and sign the informed consent form, and be able to understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Subjects who meet any of the following criteria are not suitable to participate in this study: 1. Those who have received any other postoperative therapy other than concurrent chemoradiotherapy in the past (including but not limited to c-Met inhibitor or HGF targeted drug therapy, antibody tumor drug therapy, carmustine extended-release implant therapy or intra-brain implant radiotherapy, tumor treating electrolytic radiofields); 2. Those who are unable to undergo cranial MRI examination; 3. Those who were found to have active bleeding by cranial CT or MRI scan before enrollment; 4. Have hypertension that is difficult to control, systolic blood pressure > 150mmHg and/or diastolic blood pressure > 100mmHg after treatment with antihypertensive drugs; 5. Wrongfully compensated heart failure (NYHA classification III and IV.), unstable angina, acute myocardial infarction, persistent and clinically significant arrhythmia within 3 months prior to enrollment; 6. Severe trauma or infection that affects the current anti-tumor therapy within 4 weeks prior to enrollment; 7. Major surgery within 4 weeks prior to enrollment; Those who have had bone marrow biopsy, open biopsy, and intracranial biopsy within 7 days before screening; 8. Anti-HIV (+), or anti-HCV and HCV-RNA are both (+), or HBsAg positive and HBV-DNA greater than 1000 IU/ml. If HBsAg is positive, but the HBV-DNA level is 1000-10000 IU/ml and is willing to use antiviral therapy during the study period can be enrolled; 9. Those who need long-term continuous use of hematopoietic growth factors (including granulocyte colony-stimulating factor, macrophage colony-stimulating factor, interleukin-11) or platelet transfusion to maintain platelet count >=75×109/L and absolute neutrophil count >=1.5×109/L; 10. Pregnant or lactating women, or those who plan to become pregnant during the study period; 11. Those who have used other clinical trial drugs within 30 days before the first dose of this investigational drug; 12. Those who are judged by the investigator to be unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Karnofsky Performance Status Scale;Objective Response Rate;Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, PRO-CTCAE; | — |
Countries
China
Contacts
Public ContactWu Jinsong
Huashan Hospital, Fudan University
Outcome results
None listed