Irinotecan And Bevacizumab Combined With Re-radiotherapy in Recurrent Glioblastoma

NCT ID: NCT05201326

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-22
• Study Completion Date: 2024-12-20

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 of clinical evidence-based evidence for the clinical treatment of recurrent GBM, and fill the guidelines for the treatment of recurrent GBM.

Conditions

Recurrent Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

irinotecan + bevacizumab + Re-radiotherapy

Group Type: EXPERIMENTAL

Bevacizumab，Irinotecan and Re-radiotherapy

Intervention Type: DRUG

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

Interventions

Bevacizumab，Irinotecan and Re-radiotherapy

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

JIAYI CHEN

Chief of Department of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiayi Chen, MD

Role: STUDY_DIRECTOR

Ruijin Hospital

Locations

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

fei xu, MD

Role: CONTACT

xf11976@rjh.com.cn

18964152276

Yunsheng Gao, MD

Role: CONTACT

gys11856@rjh.com.cn

Facility Contacts

Jiayi Chen, MD

Role: primary

cjy11756@rjh.com.cn

+86-021-64370045 ext. 602400

Other Identifiers

RJHGBMrRT

Identifier Type: -

Identifier Source: org_study_id