glioblastoma
Conditions
Interventions
one group:treated by Apatinib Mesylate Tablets
Sponsors
Huashan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old; 2. Diagnosis of glioblastoma by surgical pathology; 3. There is at least one intracranial target lesion defined by the neurotumor response evaluation standard (RANO) ; 4. Though accepted intracranial lesions radiotherapy and chemotherapy regimens included temozolomide, and failed (failed in treatment process or a period of 6 months after treatment confirmed by imaging examination); 5. No reoperation indication; 6. ECOG PS: 0-2 points; 7. The survival period is expected to be more than 3 months; 8. The main organ function is normal, which meets the following criteria: blood routine examination standard should be consistent with (14 days without using blood transfusion and blood products, no g-csf and other hematopoietic stimulation factor) : (1) Hb 90 g/L or higher; (2) the ANC = 1.5 x 10^9 / L; (3) PLT = 80 x 10^9/L; biochemical tests shall meet the following criteria: (1) TBIL blood routine examination standard should be consistent with (14 days without using blood transfusion and blood products, no g-csf and other hematopoietic stimulation factor) : (1) Hb 90 g/L or higher; (2) the ANC = 1.5 x 10^9 / L; (3) PLT = 80 x 10^9/L; biochemical tests shall meet the following criteria: (1) TBIL blood routine examination standard should be consistent with (14 days without using blood transfusion and blood products, no g-csf and other hematopoietic stimulation factor) : (1) Hb 90 g/L or higher; (2) the ANC = 1.5 x 10^9 / L; (3) PLT = 80 x 10^9/L; biochemical tests shall meet the following criteria: (1) TBIL blood routine examination standard should be consistent with (14 days without using blood transfusion and blood products, no g-csf and other hematopoietic stimulation factor) : (1) Hb 90 g/L or higher; (2) the ANC = 1.5 x 10^9 / L; (3) PLT = 80 x 10^9/L; biochemical tests shall meet the following criteria: (1) TBIL blood routine examination standard should be consistent with (14 days without using blood transfusion and blood products, no g-csf and other hematopoietic stimulation factor) : (1) Hb 90 g/L or higher; (2) the ANC = 1.5 x 10^9 / L; (3) PLT = 80 x 10^9/L; biochemical tests shall meet the following criteria: (1) TBIL < 1.5 by ULN; (2) ALTAST < 2.5 x ULN; (3) BUN and Cr = 1 x ULN or endogenous creatinine clearance was greater than 50ml/min (Cockcroft -Gault formula). 9. Women should accept the pregnancy test (serum) in 7 days before recruiting into group, and the results must be negative.patients must be use the appropriate methods to prevent pregnancy during the trial and 8 weeks after the last gives the experimental drug; 10. The subjects volunteered to participate in this study, sign informed consent, obey the rules and follow-up
Exclusion criteria
Exclusion criteria: 1. Patients who have high blood pressure and have been treated with antihypertensive drugs cannot be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 2. Always suffer from severe cardiovascular disease: II magnitude of myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase male 450, female 470 ms or ms or higher); According to NYHA standard, III-IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 1.0 g); 4. Abnormal coagulation function (INR > 1.5, APTT> 1.5uln), with bleeding tendency; 5. In the past 3 months, there has been a history of gastrointestinal bleeding or a definite gastrointestinal bleeding The tendency, such as: the esophageal varicose with hemorrhage, the local active ulcer lesion, fecal occult blood greater than (+ +) inentrant group; If defecate latent blood (+), request for gastroscope examination; 6. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred in the 6 months prior to the study; 7. Patients undergoing substantial organ surgery in the three months prior to the study; 8. Patients with objective evidence of pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, serious lung function, etc.; 9. According to the researchers' judgment, there are other serious patients who have the safety or influence to complete the study of patients with the disease; 10. Patients who have a history of psycho-drug abuse and are unable to quit or have mental disorders; 11. Patients who have previously used other small molecule TKI targeted drugs for treatment; 12. Multiple factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect drug use and absorption); 13. Pregnant or lactating women; 14. Patients with allergies, or allergic to similar drugs or components; 15. The researchers do not consider it suitable for inclusion; 16. Participated in other clinical trials in the 3 months prior to the study.;Exclusion criteria: 1. Patients who have high blood pressure and have been treated with antihypertensive drugs cannot be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 2. Always suffer from severe cardiovascular disease: II magnitude of myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase male 450, female 470 ms or ms or higher); According to NYHA standard, III-IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 1.0 g); 4. Abnormal coagulation function (INR > 1.5, APTT> 1.5uln), with bleeding tendency; 5. In the past 3 months, there has been a history of gastrointestinal bleeding or a definite gastrointestinal bleeding The tendency, such as: the esophageal varicose with hemorrhage, the local active ulcer lesion, fecal occult blood greater than (+ +) inentrant group; If defecate latent blood (+), request for gastroscope examination; 6. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred in the 6 months prior to the study; 7. Patients undergoing substantial organ surgery in the three months prior to the study; 8. Patients with objective evidence of pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, serious lung function, etc.; 9. According to the researchers' judgment, there are other serious patients who have the safety or influence to complete the study of patients with the disease; 10. Patients who have a history of psycho-drug abuse and are unable to quit or have mental disorders; 11. Patients who have previously used other small molecule TKI targeted drugs for treatment; 12. Multiple factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect drug use and absorption); 13. Pregnant or lactating women; 14. Patients with allergies, or allergic to similar drugs or components; 15. The researchers do not consider it suitable for inclusion; 16. Participated in other clinical trials in the 3 months prior to the study.;Exclusion criteria: 1. Patients who have high blood pressure and have been treated with antihypertensive drugs cannot be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 2. Always suffer from severe cardiovascular disease: II magnitude of myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase male 450, female 470 ms or ms or higher); According to NYHA standard, III-IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 1.0 g); 4. Abnormal coagulation function (INR > 1.5, APTT> 1.5uln), with bleeding tendency; 5. In the past 3 months, there has been a history of gastrointestinal bleeding or a definite gastrointestinal bleeding The tendency, such as: the esophageal varicose with hemorrhage, the local active ulcer lesion, fecal occult blood greater than (+ +) inentrant group; If defecate latent blood (+), request for gastroscope examination; 6. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred in the 6 months prior to the study; 7. Patients undergoing substantial organ surgery in the three months prior to the study; 8. Patients with objective evidence of pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, serious lung function, etc.; 9. According to the researchers' judgment, there are other serious patients who have the safety or influence to complete the study of patients with the disease; 10. Patients who have a history of psycho-drug abuse and are unable to quit or have mental disorders; 11. Patients who have previously used other small molecule TKI targeted drugs for treatment; 12. Multiple factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect drug use and absorption); 13. Pregnant or lactating women; 14. Patients with allergies, or allergic to similar drugs or components; 15. The researchers do not consider it suitable for inclusion; 16. Participated in other clinical trials in the 3 months prior to the study.;Exclusion criteria: 1. Patients who have high blood pressure and have been treated with antihypertensive drugs cannot be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 2. Always suffer from severe cardiovascular disease: II magnitude of myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase male 450, female 470 ms or ms or higher); According to NYHA standard, III-IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 1.0 g); 4. Abnormal coagulation function (INR > 1.5, APTT> 1.5uln), with bleeding tendency; 5. In the past 3 months, there has been a history of gastrointestinal bleeding or a definite gastrointestinal bleeding The tendency, such as: the esophageal varicose with hemorrhage, the local active ulcer lesion, fecal occult blood greater than (+ +) inentrant group; If defecate latent blood (+), request for gastroscope examination; 6. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred in the 6 months prior to the study; 7. Patients undergoing substantial organ surgery in the three months prior to the study; 8. Patients with objective evidence of pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, serious lung function, etc.; 9. According to the researchers' judgment, there are other serious patients who have the safety or influence to complete the study of patients with the disease; 10. Patients who have a history of psycho-drug abuse and are unable to quit or have mental disorders; 11. Patients who have previously used other small molecule TKI targeted drugs for treatment; 12. Multiple factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect drug use and absorption); 13. Pregnant or lactating women; 14. Patients with allergies, or allergic to similar drugs or components; 15. The researchers do not consider it suitable for inclusion; 16. Participated in other clinical trials in the 3 months prior to the study.;Exclusion criteria: 1. Patients who have high blood pressure and have been treated with antihypertensive drugs cannot be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 2. Always suffer from severe cardiovascular disease: II magnitude of myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase male 450, female 470 ms or ms or higher); According to NYHA standard, III-IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 1.0 g); 4. Abnormal coagulation function (INR > 1.5, APTT> 1.5uln), with bleeding tendency; 5. In the past 3 months, there has been a history of gastrointestinal bleeding or a definite gastrointestinal bleeding The tendency, such as: the esophageal varicose with hemorrhage, the local active ulcer lesion, fecal occult blood greater than (+ +) inentrant group; If defecate latent blood (+), request for gastroscope examination; 6. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred in the 6 months prior to the study; 7. Patients undergoing substantial organ surgery in the three months prior to the study; 8. Patients with objective evidence of pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, serious lung function, etc.; 9. According to the researchers' judgment, there are other serious patients who have the safety or influence to complete the study of patients with the disease; 10. Patients who have a history of psycho-drug abuse and are unable to quit or have mental disorders; 11. Patients who have previously used other small molecule TKI targeted drugs for treatment; 12. Multiple factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect drug use and absorption); 13. Pregnant or lactating women; 14. Patients with allergies, or allergic to similar drugs or components; 15. The researchers do not consider it suitable for inclusion; 16. Participated in other clinical trials in the 3 months prior to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;ORR; | — |
Countries
China
Contacts
Public ContactLiang Xiaohua;Liang Xiaohua;Liang Xiaohua;Liang Xiaohua;Liang Xiaohua ;;;;
department of oncology, Huashan Hospital Fudan University;department of oncology, Huashan Hospital Fudan University;department of oncology, Huashan Hospital Fudan University;department of oncology, Huashan Hospital Fudan University;department of oncology, Huashan Hospital Fudan University
Outcome results
None listed