glioblastoma
Conditions
Interventions
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Primary tumors must be Histologically confirmed as glioblastoma; 2) After surgery (including biopsy, partial nephrectomy, full cut), standard chemoradiotherapy and temozolomide chemotherapy, the primary tumor progression or recurrence, including intracranial multiple relapse and new lesions; 3) Aged 18 years old and more; 4) KPS is over 60; 5) The Expected lifetime is over 12 weeks; 6) The patient should undergo brain enhancement MRI 14 days before the inception, and the tumor on MRI must be measurable; 7) The patients who underwent the first or second palliative operation, the baseline MRI should be available at least 4 weeks after surgery; 8) If the patient is undergoing hormone therapy, the hormone dose must be stable or reduced at least 5 days prior to baseline MRI; 9) For patients with remission radiotherapy, baseline MRI should be obtained at least 8 weeks after radiotherapy or at least 4 weeks after radiotherapy (the recurrent lesions are not in the radiation field); 10) For patients who have received radiotherapy for the first time with gamma knife or other large segmentation methods, there must be pathological confirmation of recurrence or progression (except for patients with new lesions); 11) Peripheral blood, liver and kidney function are within the allowable range (these indexes should be test within 7 days prior to treatment): ANC=1.5×10^9/L; HGB=100 g/L; PLT=100×10^9/L; AST/ALT=2.5ULN; TBIL<1.5ULN; CREAT<1.2ULN; INR<1.5, APTT<1.5ULN(Except for patients with anticoagulant therapy); PRO/CREAT=1.0; 12) The patient must have fully recovered from the toxicity of previous chemotherapy or targeted therapy, at least 30 days after the most recent treatment; 13) Before the treatment of apatinib, the patient must be fully recovered from surgery, postoperative infection or other complications (postoperative), at least 30 days; 14) Patients of reproductive age (including female and male patients) must take effective birth control measures; 15) Signed the Informed Consent Form.;Inclusion criteria: 1) Primary tumors must be Histologically confirmed as glioblastoma; 2) After surgery (including biopsy, partial nephrectomy, full cut), standard chemoradiotherapy and temozolomide chemotherapy, the primary tumor progression or recurrence, including intracranial multiple relapse and new lesions; 3) Aged 18 years old and more; 4) KPS is over 60; 5) The Expected lifetime is over 12 weeks; 6) The patient should undergo brain enhancement MRI 14 days before the inception, and the tumor on MRI must be measurable; 7) The patients who underwent the first or second palliative operation, the baseline MRI should be available at least 4 weeks after surgery; 8) If the patient is undergoing hormone therapy, the hormone dose must be stable or reduced at least 5 days prior to baseline MRI; 9) For patients with remission radiotherapy, baseline MRI should be obtained at least 8 weeks after radiotherapy or at least 4 weeks after radiotherapy (the recurrent lesions are not in the radiation field); 10) For patients who have received radiotherapy for the first time with gamma knife or other large segmentation methods, there must be pathological confirmation of recurrence or progression (except for patients with new lesions); 11) Peripheral blood, liver and kidney function are within the allowable range (these indexes should be test within 7 days prior to treatment): ANC=1.5×10^9/L; HGB=100 g/L; PLT=100×10^9/L; AST/ALT=2.5ULN; TBIL<1.5ULN; CREAT<1.2ULN; INR<1.5, APTT<1.5ULN(Except for patients with anticoagulant therapy); PRO/CREAT=1.0; 12) The patient must have fully recovered from the toxicity of previous chemotherapy or targeted therapy, at least 30 days after the most recent treatment; 13) Before the treatment of apatinib, the patient must be fully recovered from surgery, postoperative infection or other complications (postoperative), at least 30 days; 14) Patients of reproductive age (including female and male patients) must take effective birth control measures; 15) Signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1) The primary tumor is a polymorous glioblastoma or a spinal metastasis tumor; 2) Spinal cord metastasis occurred during recurrence; 3) Patients who have participated in other clinical trials and have not terminated; 4) Patients who were used apatinib or other anti-VEGF/VEcabuse, or AIDS infection; 9) There are recurrent vomiting or other factors that affect the oral administration of the drug; 10) Patients with uncontrolled hypertension (>150/100mmhg); 11) Patients with hypertensive encephalopathy; 12) Patients with bleeding tendency or coagulation disorder; 13) To be treated with thrombolytic or anticoagulant (except for low molecular heparin or warfarin); 14) =level 2 cardiac dysfunction (NYHA standard) or congestive heart failure; 15) There has been a history of myocardial infarction or unstable angina pectoris, stroke and transient ischemic attack in 6 months; 16) There are serious vascular diseases; 17) There are peripheral arterial embolism Recently; 18) There are abdominal fistula, gastrointestinal perforation and abdominal abscess previously; 19) There are intracranial abscess occurred within 6 months; 20) Major surgery, open biopsy or major trauma in 28 days; 21) Major surgical operations are expected; 22) There are serious incurable wounds, ulcers or fractures; 23) An the known ingredients allergy of apatinib; 24) There is a serious skin disease.;Exclusion criteria: 1) The primary tumor is a polymorous glioblastoma or a spinal metastasis tumor; 2) Spinal cord metastasis occurred during recurrence; 3) Patients who have participated in other clinical trials and have not terminated; 4) Patients who were used apatinib or other anti-VEGF/VEcabuse, or AIDS infection; 9) There are recurrent vomiting or other factors that affect the oral administration of the drug; 10) Patients with uncontrolled hypertension (>150/100mmhg); 11) Patients with hypertensive encephalopathy; 12) Patients with bleeding tendency or coagulation disorder; 13) To be treated with thrombolytic or anticoagulant (except for low molecular heparin or warfarin); 14) =level 2 cardiac dysfunction (NYHA standard) or congestive heart failure; 15) There has been a history of myocardial infarction or unstable angina pectoris, stroke and transient ischemic attack in 6 months; 16) There are serious vascular diseases; 17) There are peripheral arterial embolism Recently; 18) There are abdominal fistula, gastrointestinal perforation and abdominal abscess previously; 19) There are intracranial abscess occurred within 6 months; 20) Major surgery, open biopsy or major trauma in 28 days; 21) Major surgical operations are expected; 22) There are serious incurable wounds, ulcers or fractures; 23) An the known ingredients allergy of apatinib; 24) There is a serious skin disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6m-PFS;6m-ORR;;6m-PFS;6m-ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;Toxicity of apatinib;The remission rate of neurological symptoms;Mental state assessment;;PFS;OS;Toxicity of apatinib;The remission rate of neurological symptoms;Mental state assessment; | — |
Countries
China
Contacts
Public ContactShaoxiong Wu;Shaoxiong Wu ;
Sun Yat-Sen University Cancer Center;Sun Yat-Sen University Cancer Center
Outcome results
None listed