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This study is a prospective, single-arm clinical trial aimed at evaluating the safety and efficacy of ivoximab combined with temozolomide in the treatment of relapsed/refractory glioma. The study plans to enroll 29 patients with relapsed/refractory glioma. After signing informed consent and meeting the inclusion/exclusion criteria through screening, patients will receive treatment with ivoximab combined with temozolomide. Efficacy evaluation will be conducted every two treatment cycles using the Response Assessment in Neuro-Oncology (RANO 2.0) criteria, and treatment will continue until disease progression or intolerance to the combined regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ivoximab combined with temozolomide | Experimental | Ivoximab 20 mg/kg, ivgtt, Q4W; Temozolomide 150 mg/m², D1-D5, P.O., Q4W. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivoximab 20 mg/kg, ivgtt, Q4W | Drug | We have not found any treatment recorded as this combination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Objective response rate | From enrollment to the end of treatment (weeks),which will be taken at 6 months, 1 year from the start of this combination of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | from the start of this treatment to death | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or breastfeeding women; Presence of any severe or uncontrolled systemic disease; Evidence of medical history or disease, treatment, or abnormal laboratory values that may interfere with the study results or prevent the subject from fully participating in the study, or other conditions deemed by the investigator as unsuitable for enrollment, including potential risks that the investigator believes would make participation in this study inappropriate.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Su, PhD | Contact | 8615890620692 | suchang0720@zzu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Zhengzhou university | Recruiting | Zhengzhou | Henan | 450000 | China |
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| Temozolomide (TMZ) | Drug | Temozolomide 150 mg/m², D1-D5, P.O., Q4W |
|
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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