Glioblastoma
Conditions
Interventions
treatment groop:hyperbaric oxygenation combined with standard treatment
control group:standard treatment
Sponsors
Tianjin Huanhu Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old; 2. Diagnosis of glioblastoma by surgical pathology; 3. There is at least one intracranial target lesion defined by the neurotumor response evaluation standard (RANO) ; 4. The survival period is expected to be more than 3 months; 5. The main organ function is normal, which meets the following criteria: blood routine examination standard should be consistent with (14 days without using blood transfusion and blood products, no g-csf and other hematopoietic stimulation factor): (1) Hb 90 g/L or higher; (2) the ANC = 1.5 x 10^9 / L; (3) PLT = 80 x 10^9/L; biochemical tests shall meet the following criteria: (1) TBIL < 1.5 by ULN; (2) ALTAST < 2.5 x ULN; (3) BUN and Cr = 1 x ULN or endogenous creatinine clearance was greater than 50ml/min (Cockcroft -Gault formula); 6. No contraindication for hyperbaric oxygenation therapy; 7. Women should accept the pregnancy test (serum) in 7 days before recruiting into group, and the results must be negative.patients must be use the appropriate methods to prevent pregnancy during the trial and 8 weeks after the last gives the experimental drug; 8. The subjects volunteered to participate in this study, sign informed consent, obey the rules and follow-up
Exclusion criteria
Exclusion criteria: 1. Patients had undergone chemotherapy and radiotherapy for glioblastoma; 2. Patients who have high blood pressure and have been treated with antihypertensive drugs cannot be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 3. Always suffer from severe cardiovascular disease: II magnitude of myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase 440 ms or higher); 4. Abnormal coagulation function (INR > 1.5, APTT> 1.5uln), with bleeding tendency; 5. Multiple factors that affect oral drugs (such as chronic diarrhea and intestinal obstruction); 6. Patients suffering from uneasily controlled epilepsy; 7. Have contraindication for hyperbaric oxygenation therapy, such as pneumothoraxpulmonary bullauncontroled internal hemorrhage, cavitary pulmonary tuberculosis along with hemoptysis, rhinitis, nasal polyps, eustachian tube obstructionand so on; 8. Person with severe uncontrolled repeated infection or other serious uncontrolled accompanying disease; 9. Pregnant or lactating women; 10. Patients was considered not suitable by researchers in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicities;ORR; | — |
Countries
China
Contacts
Public ContactJiang Wei
Tianjin Huanhu Hospital
Outcome results
None listed