Irinotecan And Bevacizumab Combined With Re-radiotherapy in Recurrent Glioblastoma

  • STATUS
    Recruiting
  • End date
    Dec 20, 2024
  • participants needed
    20
  • sponsor
    Ruijin Hospital
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Updated on 25 March 2022
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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.

Details
Condition Recurrent Glioblastoma
Treatment Bevacizumab，Irinotecan and Re-radiotherapy
Clinical Study IdentifierNCT05201326
SponsorRuijin Hospital
Last Modified on25 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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