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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: fei xu, MD
- Phone Number: 18964152276
- Email: xf11976@rjh.com.cn
Study Contact Backup
- Name: Yunsheng Gao, MD
- Email: gys11856@rjh.com.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Recruiting
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
-
Contact:
- Jiayi Chen, MD
- Phone Number: 602400 +86-021-64370045
- Email: cjy11756@rjh.com.cn
-
Principal Investigator:
- Yunsheng Gao, MD
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Treatment arm
irinotecan + bevacizumab + Re-radiotherapy
|
All patients with recurrent glioblastoma will accept irinotecan and bevacizumab combined with re-radiotherapy .
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
serious adverse events (SAE)
Time Frame: From baseline to 28 days after the end of treatment
|
Clinical safety
|
From baseline to 28 days after the end of treatment
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
overall survival
Time Frame: From the beginning of treatment to death or the last follow-up, approximately 24 months
|
the time between the date of enrollment of the patient and death from any cause
|
From the beginning of treatment to death or the last follow-up, approximately 24 months
|
|
progression free survival
Time Frame: From the start of treatment to the date of disease progression or death, up to approximately 24 months
|
The time between the patient's enrollment and any documented tumor progression or death from any cause.
|
From the start of treatment to the date of disease progression or death, up to approximately 24 months
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life score
Time Frame: Receive once every two months until you cannot tolerate toxicity or PD, up to about 24 months
|
European Organization for Cancer Research and Treatment Quality of Life Questionnaire (EORTC QLQ-C30) Version 3.0 EORTC QLQ-C30 (Version 3.0) questionnaire for assessing quality of life.
|
Receive once every two months until you cannot tolerate toxicity or PD, up to about 24 months
|
|
Cognitive function
Time Frame: Receive once every two months until you cannot tolerate toxicity or PD, up to about 24 months
|
The Mental State Test (MMSE, with a score ranging from 0 to 30) to assess cognitive function.
|
Receive once every two months until you cannot tolerate toxicity or PD, up to about 24 months
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Jiayi Chen, MD, Ruijin Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Recurrence
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Topoisomerase I Inhibitors
- Bevacizumab
- Irinotecan
Other Study ID Numbers
Other Study ID Numbers
- RJHGBMrRT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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