glioblastoma multiforme
Conditions
Interventions
Experimental group:Genexol-PM combined with standard postoperative chemoradiotherapy
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study, signed the informed consent, and had good compliance; 2. Age: 18-75 years old (when signing the informed consent); ECOG score: 0-2; Expected survival of more than 3 months; 3. The glioblastoma proved by histology was completely resected by MR After surgical treatment; 4. The main organs function well and meet the following criteria: a. Blood routine should meet the following test criteria (no blood transfusion within 7 days before randomization, no hematopoietic stimulating drug correction) : hemoglobin (HGB) =90g/L; Neutrophil absolute value (NEUT) =1.5×109/L; Platelet count (PLT) =90×109/L. b. Blood biochemical tests should meet the following criteria: total bilirubin =1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (ALP) =2.5 times ULN (ALT, AST or ALP =5×ULN for subjects with liver metastasis); Serum creatinine =1.5 times ULN or creatinine clearance (calculated by Cockcroft-Gault formula) =60 ml/min; c. Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) =1.5 times ULN (no anticoagulant therapy); 5. For female subjects of reproductive age, a urine or serum pregnancy test should be performed negative within 3 days prior to receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy; If there is a risk of conception, all subjects (male or female) are required to use contraception for the entire duration of treatment up to 180 days after the last study drug administration.
Exclusion criteria
Exclusion criteria: 1. Patients who cannot receive MRI examination; 2. Radiologically significant diffuse meningeal diffusion; 3. Patients whose imaging (CT/MRI) shows that the tumor has invaded important blood vessels, or who are judged by the investigators to be highly likely to invade important blood vessels and cause fatal massive bleeding, cerebrovascular malformations or other bleeding tendencies during the follow-up study; 4. Occurrence of arteriovenous thrombosis/cancer embolus events within 6 months, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 5. Have had or are currently suffering from other malignant tumors within 3 years. The following two conditions can be included: other malignancies treated with a single operation, achieving continuous 5-year disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basal membrane)]; 6. Have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, and enterocele) Resistance, etc.); 7. Subjects with any severe and/or uncontrolled medical condition, including: a) Poor blood pressure control (systolic =150mmHg or diastolic =100 mmHg); b) have grade 2 myocardial ischemia or myocardial infarction, arrhythmia (including QTc =450ms(male), QTc =470ms(female)), and grade 2 congestive heart failure (NYHA); c) Active or uncontrolled severe infection (=CTC AE grade 2 infection); d) Present pneumonia with CTC-AE grade =2; e) A known history of clinically significant liver disease. Active HBV infection, i.e., positive HBV DNA (>2500 copies /mL or >500IU/mL, and greater than the upper limit of normal) must be excluded for known hepatitis B virus (HBV) carriers; Known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL), or other decompensated liver disease; f) a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; g) Poor diabetes control (fasting blood glucose (FBG) > 10mmol/L); h) Urine routine indicated urine protein =++, and confirmed 24-hour urine protein quantity > 1.0 g; i) there is a clinically significant thyroid function abnormality, and the thyroid function does not return to normal or is not clinically significant even in the case of drug therapy; 8. Have a clear history of neurological disease or mental illness, moderate or above epilepsy (excluding mild epilepsy secondary to grade IV glioblastoma), moderate or above aphasia or dementia; 9. Participated in clinical trials of other antitumor drugs within 4 weeks before grouping; 10. Subjects with concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are not suitable for enrollment for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate, DCR;overall response rate, ORR;Overall Survival,OS; | — |
Countries
China
Contacts
Public ContactYuandong Cao
Jiangsu Province Hospital
Outcome results
None listed