irinotecan and bevacizumab combined with re-radiotherapy in recurrent glioblastoma

Conditions: Recurrent Glioblastoma

Summary: this is a phase i study to observe the safety and efficacy of irinotecan and bevacizumab combined with re-radiotherapy in the treatment of recurrent glioblastoma. the study will provide a higher level of clinical evidence-based evidence for the clinical treatment of recurrent gbm, and fill the guidelines for the treatment of recurrent gbm.


Eligibility criteria:
inclusion criteria: 1. the initial diagnosis confirmed by histopathology is world health organization who grade 4 glioma; 2. surgery, radiotherapy, chemotherapy, and adjuvant chemotherapy (stupp plan) are performed after the initial diagnosis, and recurrence according to the evaluation of neurotumor response (rano) criteria and/or confirmed by histopathology; 3. the expected survival period is ≥3 months; 4. age between 18 and 70 years old; 5. kps score (kps) ≥ 70, able to take care of most of life, but occasionally need help from others; 6. there are measurable lesions on the t1 enhancement sequence of the head mri; 7. hematopoietic function: hemoglobin ≥90g/l, platelets ≥90×109/l, white blood cells ≥4×109/l (previous chronic anemia 80-90 g/l or previous low white blood cell level 3-4×109/l or thrombocytopenia 80-90×109/l, but kps 70-100 can be considered for admission) (the range of normal values can be fine-tuned due to the different standards of tertiary first-class hospitals); 8. liver function: alt and ast\<1.5 times of high normal (uln), bilirubin\<1.5×uln; 9. sign the informed consent form; 10. agree to participate in follow-up actions. exclusion criteria: 1. other invasive malignant tumors; 2. re-irradiation after receiving recurrence in the past; 3. recurrence more than 3 times or evidence that there is a subdural recurrence disease or a tumor with a maximum diameter of more than 6 cm; 4. treat with vascular endothelial growth factor (vegf) or vegfr inhibitor or irinotecan in advance; 5. pregnant or nursing mothers; 6. participate in other tests after diagnosis of recurrence; 7. according to ctcae5.0 standard classification of patients with bleeding above grade 3; 8. symptomatic peripheral vascular disease; 9. known allergy to bevacizumab or irinotecan; 10. patients who are treated with anticoagulants or vitamin k antagonists such as warfarin, heparin or their analogs; under the premise that the prothrombin time international normalized ratio (inr) is ≤1.5, the use of small doses of huafa for preventive purposes is allowed farin (1 mg orally, once a day) or low-dose aspirin (do not exceed 100 mg per day); 11. abnormal blood coagulation function, bleeding tendency (such as active peptic ulcer) or receiving thrombolysis or anticoagulation therapy; 12. arterial/venous thrombotic events that occurred within 6 months before the first medication, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 13. urine routine test showed urine protein ≥++ and confirmed 24-hour urine protein quantification\>1.0 g; 14. long-term unhealed wounds or fractures; 15. suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade ii, poor arrhythmia control (including men with qtc interval ≥450 ms, women ≥470 ms); according to nyha standards, iii to grade iv insufficiency or color doppler ultrasonography of the heart shows that the left ventricular ejection fraction (lvef) is less than 50%; 16. patients with hypertension who cannot be well controlled by a single antihypertensive drug treatment (systolic blood pressure\> 140 mmhg, diastolic blood pressure\> 90 mmhg), suffering from myocardial ischemia or myocardial infarction, arrhythmia (including qt room period ≥440 ms) and degree i cardiac insufficiency; 17. history of organ transplantation; 18. according to the judgment of the researcher, a serious disease that endangers the safety of the patient or affects the completion of the study. 19. poor overall health, even kps\<60; 20. unable to understand the purpose of treatment or unwilling to sign the treatment consent form; 21. no capacity for civil conduct or limited capacity for civil conduct.