Glioma
Conditions
Interventions
single arm:Temozolomide 100mg/mm2 Po, take for 7 days and stop for 7 days
Apatinib 250mg, PO, QD
Sponsors
Shanxi Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old, male or female; 2. According to the Rano standard, the patients with high-grade gliomas that recurred for the first time had definite measurable lesions; 3. KPS score: >= 60; 4. Subjects with an expected survival time of more than 3 months; 5. Subjects with normal main organ function met the following criteria (no blood transfusion or blood products within 14 days, no correction with G-CSF or other hematopoietic stimulating factors). 6. (1) the standard of blood routine examination should meet the following requirements: HB >= 90 g/L ANC >= 1.5 x 10^9/L PLT >= 80 x 10^9/L (2) Biochemical tests should meet the following standards: TBIL 45 ml / min; 7. Women of childbearing age must have negative pregnancy test (serum or urine) results within 7 days before enrollment, and voluntarily use appropriate contraceptive methods during the observation period and within 8 weeks after the last administration of apatinib; for men, it should be surgical sterilization, or agree to use appropriate contraceptive methods during the observation period and within 8 weeks after the last administration of apatinib; 8. The subjects who voluntarily joined the study signed the informed consent; 9. Subjects who the researchers believe can benefit.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with contraindications of apatinib (such as active bleeding, ulcer, intestinal perforation, intestinal obstruction, uncontrollable hypertension, III-IV cardiac insufficiency, 30 days after major surgery, severe liver and kidney dysfunction, etc.); 3. Subjects who can not be examined by MRI (such as pacemaker, metal denture, etc.); 4. Subjects with persistent clinical treatment-related toxicity related to previous chemotherapy and / or radiotherapy; 5. Subjects with clinically significant hemoptysis in the past 3 months; 6. Subjects treated with anticoagulants or antiplatelet drugs; 7. Subjects with abnormal coagulation function (INR > 1.5 x ULN, APTT > 1.5 x ULN) and bleeding tendency; 8. Subjects with severe thrombosis or clinically related severe bleeding events in the past 6 months, with hereditary bleeding or thrombotic tendency; 9. Subjects with hypertension who could not be reduced to normal after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 10. The researcher judges other situations that may affect the judgment of clinical research results. 11. Subjects considered unsuitable by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Countries
China
Contacts
Public ContactGong Zhang
Shanxi Provincial People's Hospital
Outcome results
None listed