High-Grade Glioma
Conditions
Interventions
Intervention group:
Ivonescimab (10 mg/kg, Q3W, d1) combined with intracranial focal re-irradiation (30 Gy/5f QOD)
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate in this clinical study, understand the study procedures, and be able to provide written informed consent; 2.Age 18-75 years, regardless of gender; 3.Diagnosed with grade 4 glioma according to the 2021 WHO Classification of Tumors of the Central Nervous System, including but not limited to glioblastoma, grade 4 astrocytoma, etc; 4.Previously treated with standard therapies such as surgery and/or radiotherapy and/or chemotherapy, with confirmed recurrence by imaging (MRI or PET) or histopathology, and not suitable for or refusing re-resection, or having residual disease after surgery; 5.At least 6 months since the last radiotherapy, unless presenting with a new lesion outside the previous radiation field; 6.No severe abnormalities of the hematologic, cardiac, pulmonary, hepatic, or renal systems, and no immunodeficiency; 7.Karnofsky Performance Status (KPS) score >=60; 8.Expected survival >=3 months; 9.Corticosteroid dose equivalent to dexamethasone <=4 mg/day within 1 week before the first dose.
Exclusion criteria
Exclusion criteria: 1.Previous participation in any investigational drug or device treatment; 2.Tumor recurrence has occurred 3 times or more; 3.The current recurrent tumor has been treated with re-irradiation; 4.Imaging suggests the recurrent lesion is located in the infratentorial region, meninges, or extracranial site, or is =Grade III, myocardial infarction or cerebrovascular accident within 3 months before the first dose, unstable arrhythmia or angina pectoris within 1 month before treatment; 13.Any arterial thromboembolic event (such as myocardial infarction, stroke, or transient ischemic attack) within 6 months before enrollment, or a history of severe thrombosis such as deep vein thrombosis or pulmonary embolism; 14.Pregnant or breastfeeding women; 15.Inability to undergo MRI examination (e.g., presence of a cardiac pacemaker, non-removable metal implants, claustrophobia, etc.); 16.Any medical, psychiatric, or social condition judged by the investigator that may compromise the subject's safety, rights, study execution, or interpretation of results; 17.Presence of severe systemic diseases unrelated to the tumor or serious tumor-related complications (such as leukemoid reaction, significant cachexia, etc.) that may pose high medical risks or interfere with survival assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment-Related Adverse Event;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactJun Yin
Sichuan Cancer Hospital
Outcome results
None listed