Clinical trial · Interventional
Irinotecan And Bevacizumab Combined With Re-radiotherapy in Recurrent Glioblastoma
An Open and Single-arm Prospective Clinical Study of the Safety and Efficacy of Irinotecan and Bevacizumab Combined With Re-radiotherapy in the Treatment of Recurrent Glioblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab,Irinotecan and Re-radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment arm
- description
- irinotecan + bevacizumab + Re-radiotherapy
- interventionNames
- Drug: Bevacizumab,Irinotecan and Re-radiotherapy
Primary outcomes (1)
- measure
- serious adverse events (SAE)
- timeFrame
- From baseline to 28 days after the end of treatment
- description
- Clinical safety
Secondary outcomes (2)
- measure
- overall survival
- timeFrame
- From the beginning of treatment to death or the last follow-up, approximately 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
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