newly diagnosed glioblastoma with unmethylated MGMT
Conditions
Interventions
Group 1:Apatinib combined with temozolomide
Group 2:temozolomide
Sponsors
Sanbo Brain Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-70 years old, male or female; (2) newly diagnosed primary supratentorial glioblastoma confirmed by histopathology; (3) after surgery, radiotherapy with concomitant TMZ was accepted, and the interval between enrollment and completion of radiotherapy was more than or equal to 4 weeks (>= 28 days); (4) without chemotherapy after concurrent radiochemotherapy; (5) general condition score KPS is greater than or equal to 60; (6) MGMT promoter has no methylation; (7) if the patient is on glucocorticoid therapy, the hormone dosage should be stable or decreased at least 5 days before baseline MRI; (8) the patient has no dysfunction of major organs, and the specific test indexes require that the leucocyte is greater than or equal to 3.0 x 10^9/L, neutrophil is greater than or equal to 1.5 x 109/L, platelet is greater than or equal to 75 x 10^9/L, hemoglobin > 10g/dl, and serum bilirubin is not higher than 1.5 times upper limit of normal value (ULN), ALT and AST were not more than 2.0 x ULN, creatinine was not more than 1.5 x ULN; (9) both men and women at the gestational age must agree to take adequate contraceptive measures throughout the study period or to conduct a pregnancy test (serum or urine) within 7 days prior to enrollment with negative results and be willing to use appropriate methods of contraception during the study period and 8 weeks after the last administration of the test drug.For men, consent is required to use appropriate methods of contraception or to be surgically sterilized during the trial and 8 weeks after the last administration of the test drug; (10) The subjects volunteered to participate in this study, understood and were willing to sign the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: Patients with any one of the following cannot be enrolled in this study: (1) received other anti-tumor chemotherapy after chemoradiotherapy; (2) the patient is using other research drugs; (3) the patient is using warfarin or warfarin-derived anticoagulants; (4) receiving enzyme-inducing antiepileptic drugs (EIAEDs), unless the drugs have been replaced with non-EIAEDs for at least 2 weeks away from enrollment; (5) patients with other malignant tumors, unless they have lived without progression for 5 years and the researchers believe that the risk of recurrence is low or patients with carcinoma in situ; (6) uncontrolled hypertension (systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg, despite optimal medication); (7) abnormal coagulation function (INR >1.5 or PT > ULN+4 seconds or APTT > 1.5uln), with bleeding tendency or receiving thrombolytic or anticoagulant treatment; (8) there were clinically significant bleeding symptoms or clear bleeding tendency in the first 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, gastrointestinal perforation, baseline fecal occult blood ++ or above, intratumor or intracranial bleeding, or vasculitis; (9) arteriovenous thrombosis events occurred within 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; (10) major surgery or severe traumatic injury, fracture or ulcer occurred within 28 days before the study; (11) has a variety of factors that significantly affect oral drug absorption, such as chronic diarrhea and intestinal obstruction; (12) the urine routine indicated that the urine protein was greater than ++, or confirmed that the urine protein was greater than or equal to 1.0g within 24 hours; (13) women who are pregnant or breast-feeding;Patients with fertility are unwilling or unable to take effective contraceptive measures; (14) Other conditions considered by the researchers to affect the trial conduction or the outcome of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSF-6%; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;progression-free survival;disease control rate;objective response rate;Evaluation of quality of life;Maintenance time of KPS=70;Glucocorticoid use; | — |
Countries
China
Contacts
Public ContactJun-ping Zhang
Sanbo Brain Hospital, Capital Medical University
Outcome results
None listed