Status:
UNKNOWN
Irinotecan And Bevacizumab Combined With Re-radiotherapy in Recurrent Glioblastoma
Lead Sponsor:
Ruijin Hospital
Conditions:
Recurrent Glioblastoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- The initial diagnosis confirmed by histopathology is World Health Organization WHO grade 4 glioma;
- 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;
- The expected survival period is ≥3 months;
- Age between 18 and 70 years old;
- KPS score (KPS) ≥ 70, able to take care of most of life, but occasionally need help from others;
- There are measurable lesions on the T1 enhancement sequence of the head MRI;
- 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);
- Liver function: ALT and AST\<1.5 times of high normal (ULN), bilirubin\<1.5×ULN;
- Sign the informed consent form;
- Agree to participate in follow-up actions.
Exclusion
- Other invasive malignant tumors;
- Re-irradiation after receiving recurrence in the past;
- 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;
- Treat with vascular endothelial growth factor (VEGF) or VEGFR inhibitor or irinotecan in advance;
- Pregnant or nursing mothers;
- Participate in other tests after diagnosis of recurrence;
- According to CTCAE5.0 standard classification of patients with bleeding above grade 3;
- Symptomatic peripheral vascular disease;
- Known allergy to bevacizumab or irinotecan;
- 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);
- Abnormal blood coagulation function, bleeding tendency (such as active peptic ulcer) or receiving thrombolysis or anticoagulation therapy;
- 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;
- Urine routine test showed urine protein ≥++ and confirmed 24-hour urine protein quantification\>1.0 g;
- Long-term unhealed wounds or fractures;
- 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%;
- 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;
- History of organ transplantation;
- According to the judgment of the researcher, a serious disease that endangers the safety of the patient or affects the completion of the study.
- Poor overall health, even KPS\<60;
- Unable to understand the purpose of treatment or unwilling to sign the treatment consent form;
- No capacity for civil conduct or limited capacity for civil conduct.
Key Trial Info
Start Date :
December 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05201326
Start Date
December 22 2021
End Date
December 20 2024
Last Update
January 21 2022
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025