Irinotecan And Bevacizumab Combined With Re-radiotherapy in Recurrent Glioblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05201326
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ruijin Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jiayi Chen, MD
Principal Investigator Affiliation Ruijin Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Recurrent Glioblastoma
Arms & Interventions

Arms

Experimental: Treatment arm

irinotecan + bevacizumab + Re-radiotherapy

Interventions

Drug: - Bevacizumab,Irinotecan and Re-radiotherapy

All patients with recurrent glioblastoma will accept irinotecan and bevacizumab combined with re-radiotherapy .

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Shanghai, Shanghai, China

Status

Recruiting

Address

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai, 200025

Site Contact

Jiayi Chen, MD

[email protected]

+86-021-64370045 #602400

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