Malignant glioblastoma (WHO Central nervous system tumor classification III-IV)
Conditions
Interventions
Test Group:Xihuang Pill Combined with Targeted Antitumor Angiogenesis Drugs for the Treatment of Advanced Glioma
Sponsors
The First Affiliated Hospital of Ningbo University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1: Pathologically confirmed as malignant glioma (WHO Central nervous system tumor classification III-IV) 2: Complete surgical resection+postoperative concurrent radiotherapy and chemotherapy+Temozolomide adjuvant chemotherapy (base note intensity modulated radiotherapy The total radiation dose is 55~60Gy. During radiotherapy, Temozolomide is 75 mg/m2, and synchronous chemotherapy is conducted once a day. After radiotherapy, Temozolomide is 150~200 mg/m2, and it is taken continuously for 5 days. 28 days is a cycle of adjuvant chemotherapy) 3: Age>18 years old 4: Expected survival time>12 months; 5: Karnofsky functional status score = 60 6: The main organs function well and meet the following requirements (excluding the use of any blood within 14 days before the first medication)Fluid composition and cell growth factors: Blood routine examination: Hemoglobin = 90 g/L (no blood transfusion within 14 days); Neutrophil count>1.5 × 109/L; Platelet count = 75 × 109/L; Biochemical examination: Total bilirubin = 1.5 × ULN (upper limit of normal value);Blood glutamic acid transaminase (ALT) or blood glutamic acid transaminase (AST) = 2.5 × ULN; If there is liver metastasis, ALT or AST = 5 × ULN; AKP = 2.5 times ULN; Endophytic creatinine clearance rate = 60 ml/min (Cockcroft Fault formula); Serum albumin = 30g/dL; No life-threatening electrolyte abnormalities; 7:Great compliance, and family members agree to cooperate in receiving survival follow-up 8: Patient informed consent.
Exclusion criteria
Exclusion criteria: 1: Patients with malignant gliomas classified as I-II in the WHO Central Nervous System Tumor Classification 2: Individuals who have previously received targeted anti angiogenic drug therapy 3: Concomitant severe heart, lung, liver, and kidney diseases 4: Arterial or venous thrombotic events occurred within 6 months before screening, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (except for venous thrombosis caused by venous catheterization in the early stage of chemotherapy, which is judged by the investigator to be cured) and pulmonary embolism 5: Concomitant infectious diseases such as tuberculosis and viral hepatitis 6: Merge uncontrolled hypertension, hemorrhagic diseases, and long-term unhealed wounds or incomplete healing fractures 7: Individuals with a history of abuse of psychotropic substances who are unable to quit or have mental disorders 8: There are multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction) 9: Individuals with abnormal coagulation function and a tendency to bleed (must meet the following requirements 14 days before enrollment: without using anticoagulants In the case of INR within the normal range);Use anticoagulants or vitamin K antagonists such as warfarin, liver Patients treated with heparin or its analogues; Assuming that the international standardized ratio (INR) of prothrombin time is = 1.5 Allow the use of low-dose warfarin (1 mg po qd) or low-dose aspirin (daily) for preventive purposes Dosage not exceeding 100 mg); Known genetic or acquired bleeding and thrombotic tendencies (such as in blood friend patients), Coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) 10: According to the judgment of the investigator, there are diseases that seriously endanger the safety of patient safety or affect the completion of the study 11: The researchers believe that patients (such as pregnant and lactating women) are not suitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progressive disease; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of quality of life;safety; | — |
Countries
China
Contacts
Public ContactHongBin Xu
The First Affiliated Hospital of Ningbo University
Outcome results
None listed