glioblastoma
Conditions
Interventions
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Signing the informed consent; 2.Ages 18-75 years; 3.Newly diagnosed glioblastoma confirmed histologically or cytologically (refer to WHO (2016) Classification of tumors of the central nervous system); 4.EGFR positive immunohistochemical test: the immunohistochemical result is +++, or ++ (need FISF test to confirm); 5.Fertile men or women willing to use contraception in the trial, women of reproductive age must have a pregnancy test within 7 days before the first administration of the drug and the results are negative; 6.No severe hematopoietic dysfunction, abnormal functions of heart, lung, liver and kidney, or immune deficiency, and the laboratory examination results before enrollment were in line with: Hematological indicators were basically normal: white blood cell count >=4x10^9/L; Absolute neutrophils count >=1.5x10^9/L;platelet 100 x 10^9/L or higher; Hemoglobin >=90g/L; Renal function was basically normal: serum creatinine =60mL/min; Liver function was basically normal: serum total bilirubin <=1.5xULN (in case of liver metastasis, serum total bilirubin should be <=3.0xULN); AST and ALT <=2.0xULN (if liver metastasis <=5.0xULN); The blood coagulation function was basically normal: the international standardized ratio of prothrombin time (INR) <=2.0, PT, APTT and TT were all within the normal range.
Exclusion criteria
Exclusion criteria: 1.Subject has uncontrollable infection, uncontrollable epilepsy and/or high intracranial pressure and/or hypertension and/or hyperglycemia; 2.Patients with human immunodeficiency virus (HIV) or active hepatitis B (HBsAg positive and HBV-DNA positive) or hepatitis C (HCV antibody positive); 3.Major surgery was performed within 4 weeks before enrollment; Screening patients who had undergone bone marrow biopsy, open biopsy, or intracranial biopsy within 7 days before the screening; 4.Other malignant tumors that have not been effectively controlled within the last 5 years, except for carcinoma in situ of the cervix, squamous cell carcinoma of the skin, or localized basal cell skin cancer; 5.Other reasons for unsuitable participation in this study as judged by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;1 year rate of OS;1 year rate of PFS;Safety; | — |
Countries
China
Contacts
Public ContactFeng Shiyu
Outcome results
None listed