glioma
Conditions
Interventions
Experimental group:Temozolomide plus Apatinib
Sponsors
Department of Neurosurgery, Nanfang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-70 years old; (2) Karnofsky function status score (KPS) =60; (3) The primary tumor was histopathologically diagnosed as glioblastoma, and after surgery (including biopsy, partial excision, total excision), standard radiotherapy, and temozolomide adjuvant chemotherapy (standard Stupp regimen), one of the following conditions occurred: a) Tumor progression or recurrence: disease progression (tumor recurrence) as assessed by the neurotumor Clinical Efficacy Evaluation Method (RANO criteria) and confirmed by pathology; b) Pseudoprogression: MRI and PET were performed 1 month after radiotherapy/chemotherapy to confirm the appearance of pseudoprogression; (4) Have measurable or evaluable lesions confirmed by magnetic resonance imaging (MRI) and have a life expectancy of at least 8 weeks; (5) Adequate bone marrow function (white blood cell count =4000/µL, neutrophil count =1500/µL, platelet count =100,000/µL, hemoglobin =8.0g/dL), renal function (serum creatinine =150µmol/L, 24-hour urine protein =3.4g) and liver function (total bilirubin =34µmol/L, aspartic acid and alanine aminotransferase =120U/L). (6) The subjects voluntarily participate in the clinical study, fully understand the purpose, procedure and content of the study, are willing to follow and have the ability to complete all test procedures and abide by the prohibitions and constraints stipulated in the study protocol, and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) extracranial metastatic disease; (2) Past or ongoing treatment with carustine wafer implant (Gliadel); (3) previous treatment with Apatinib; (4) severe cardiopulmonary insufficiency; (5) epileptic state; (6) Pregnant or lactating women; (7) gastrointestinal bleeding; (8) Uncontrolled blood pressure after medication (> 140/90mmHg); (9) Recurrent vomiting, dysphagia or other conditions affecting oral administration of drugs; (10) HIV positive and antiretroviral therapy; (11) Patients who are currently participating in other clinical trials, or who have participated in previous trials that have not been terminated; (12) Other conditions deemed unsuitable for participation in this study by the investigator.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Objective response rate ORR;Disease control rate DCR; | — |
Primary
| Measure | Time frame |
|---|---|
| Overall survival OS; | — |
Countries
China
Contacts
Public ContactGuang-long Huang
Department of Neurosurgery, Nanfang Hospital of Southern Medical University
Outcome results
None listed