Irinotecan And Bevacizumab Combined With Re-radiotherapy in Recurrent Glioblastoma

Last updated: January 20, 2022
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Gliomas

Astrocytoma

Treatment

N/A

Clinical Study ID

NCT05201326
RJHGBMrRT
  • Ages 18-75
  • All Genders

Study 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

Inclusion Criteria:

  1. The initial diagnosis confirmed by histopathology is World Health Organization WHOgrade 4 glioma;
  2. Surgery, radiotherapy, chemotherapy, and adjuvant chemotherapy (Stupp plan) areperformed after the initial diagnosis, and recurrence according to the evaluation ofneurotumor 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 helpfrom 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 foradmission) (The range of normal values can be fine-tuned due to the differentstandards 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

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 diseaseor a tumor with a maximum diameter of more than 6 cm;
  4. Treat with vascular endothelial growth factor (VEGF) or VEGFR inhibitor or irinotecanin 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 aswarfarin, heparin or their analogs; under the premise that the prothrombin timeinternational normalized ratio (INR) is ≤1.5, the use of small doses of Huafa forpreventive purposes is allowed Farin (1 mg orally, once a day) or low-dose aspirin (donot 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 firstmedication, 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 proteinquantification>1.0 g;
  14. Long-term unhealed wounds or fractures;
  15. Suffering from severe cardiovascular disease: myocardial ischemia or myocardialinfarction 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 orcolor Doppler ultrasonography of the heart shows that the left ventricular ejectionfraction (LVEF) is less than 50%;
  16. Patients with hypertension who cannot be well controlled by a single antihypertensivedrug treatment (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg),suffering from myocardial ischemia or myocardial infarction, arrhythmia (including QTroom 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 thesafety 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 treatmentconsent form;
  21. No capacity for civil conduct or limited capacity for civil conduct.

Study Design

Total Participants: 20
Study Start date:
December 22, 2021
Estimated Completion Date:
December 20, 2024

Connect with a study center

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

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