Giloblastoma
Conditions
Interventions
Experimental group 1:Anlotinib relieve encephaledema
Experimental group 2:Anlotinib treat recurrent glioblastoma
Experimental group 3:Anlotinib Combined with penpulimab treat recurrent glioblastoma
Control group:Temozolomide chemotherapy
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1)Diagnosed glioblastoma by pathology; 2)The patient who received total resection and standard temozolomide concurrent chemoradiotherpy plus temozolomide adjuvant chemotherapy and then relapse, and those also received the test of CD8 T cells and the genes targeted by anlotinib; 3)Age = 18 years; 4)KPS =60; 5)Performed MR after surgery and before radiotherapy; 6)Steroid duge discontinued more than one week; 7)Haematological testing results and liver or kidney function in permissible range; —ANC=1.5×10^9/L; —HGB=100 g/L; —PLT =100×10^9/L; —AST/ALT=2.5×ULN; —TBIL<1.5×ULN; —CREAT<1.2×ULN; —INR<1.5; —APTT<1.5×ULN(except those received anticoagulation therapy); —PRO/CREAT =1.0; 8)Contraception in both male and female; 9)Signed informed consent.
Exclusion criteria
Exclusion criteria: 1)Participate in other clinical trials 2)Have treated by anlotinib or other antiangiogenic agents 3)Cerebral hemorrhage or hernia 4)Femal in pregnancy or lactation 5)Uncontrollable infection 6)Drug abuser, alcoholics, HIV sufferers 7)Frequently vomit impede taking medicine 8)Hypertension uncontrolled by drug 9)Hypertensive encephalopathy 10)Bleeding propensity or coagulation disorders 11)Receiving thrombolytic therapy or anticoagulant therapy 12)Cardiac dysfunction = 2 grade 13)Myocardial infarction history and unstable angina pectoris, stroke or transient cerebral ischemia in 6 months 14)Severe vascular disease 15)Peripheral arterial thrombosis in recent 16)Abdominal fistula or abscess, gastric-intestinal perforation 17)Intracranial abscess in 6 months 18)Major surgery, openness biopsy, or Severe trauma in 28 days 19)Be going to major surgery 20)Unhealing wound, ulcer, fracture 21)Allergy to anlotinib or penpulimab 22)Severe dermatosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Encephaledema volume;Progress Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Countries
China
Contacts
Public ContactShen Guoping
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed