Glioblastoma
Conditions
Interventions
Sponsors
the First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Glioblastoma after partial resection or biopsy (IDH wild-type): The tumor is located in the dominant hemisphere, with extensive invasive growth or invasion of both hemispheres; The tumor is located in the cortex, deep white matter, or brainstem of the functional area and cannot be satisfactorily removed; And improve the detection of molecular biological markers (MGMT, 1p/19q, IDH,TERT,BRAF,p53,EGFR); 2) There are lesions that can be evaluated according to Rano criteria; 3) Age range from 18 to 75 years old; 4) The KPS score is less than 60. 5) The dosage of corticosteroid therapy has remained stable or gradually decreased in the past 5 days; 6) Has not received any anti-tumor treatments such as radiotherapy, chemotherapy, immunotherapy, or biological therapy in the past; 7) Serum hemoglobin = 100g/L, platelet = 80 × 109/L, absolute neutrophil count = 1.5 × 109/L; 8) Serum creatinine = 1.25 times UNL or creatinine clearance rate = 60 mL/min; 9) Serum bilirubin = 1.5 times UNL, AST (SGOT) and ALT (SGPT) = 2.5 times UNL, alkaline phosphatase = 5 times UNL; 10) Normal coagulation function (PT prolongation not exceeding 3 seconds, APTT prolongation not exceeding 10 seconds); 11) Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and are willing to use appropriate methods of contraception during the trial period and within 6 months after the last administration of the investigational drug. For males, they must agree to use appropriate methods of contraception or undergo surgical sterilization during the trial period and within 6 months after the last administration of the investigational drug; 12) The subjects are able to comply with the research and follow-up procedures; The subjects signed a formal informed consent form to demonstrate their understanding that this study complies with the hospital's policies and ethical requirements.
Exclusion criteria
Exclusion criteria: 1) Previously or currently suffered from any other malignant tumors; 2) Glioma with widespread spread of cerebrospinal fluid and meningeal metastasis 3) Any other disease or condition that is contraindicated to radiotherapy and chemotherapy (such as active infection, symptomatic heart disease within 6 months after myocardial infarction, including unstable angina, congestive heart failure, or uncontrolled arrhythmia, immunosuppressive therapy); 4) Pregnant or lactating women; 5) Women and men who may become pregnant but are unwilling to take appropriate contraceptive measures; 6) Evidence of hereditary hemorrhagic constitution or coagulation disorders; 7) Anticoagulant treatment is required due to other diseases; HBV positive and combined with liver dysfunction (total bilirubin>1.5 times ULN; ALT and AST>2.5 times ULN; If there is liver metastasis, ALT and AST are greater than 5 times ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;Treatment failure mode;Treatment related toxicity;Quality of life;cognitive function; | — |
Countries
CHINA
Contacts
Public ContactSenxiang Yan,Danfang Yan
the First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed