Glioblastoma multiforme
Conditions
Interventions
Experimental Group:Selective internal radiotherapy (SIRT) with yttrium-90 resin microspheres
Sponsors
Beijing Tsinghua Changgung Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, willing to participate in the trial, and able to sign the informed consent form; 2. Expected survival >=12 weeks; 3. The participant is willing and able to comply with the study examinations, intervention, and follow-up schedule; 4. Histopathologically and molecularly confirmed glioma with an integrated diagnosis of IDH-wildtype, in accordance with the 2021 WHO Classification of Tumors of the Central Nervous System, with a pathological grade of Grade 4; 5. Definite tumor progression or recurrence confirmed by contrast-enhanced MRI according to the Response Assessment in Neuro-Oncology (RANO) criteria, with at least one measurable enhancing lesion (bidimensional diameter >=1 cm and =60, as detailed in Table 1; 8. The interval since completion of cranial radiotherapy must be >6 months. If tumor recurrence or progression outside the previously irradiated field has been histologically confirmed, the interval since completion of cranial radiotherapy must be at least 12 weeks; 9. Confirmed by multidisciplinary team (MDT) assessment or neurosurgical consultation to be unsuitable for repeat gross total or subtotal tumor resection, and with no other indication for curative surgery; 10. The interval from the last chemotherapy or targeted therapy to the planned intervention date must be >=1 treatment cycle or >=2 biological half-lives, specifically: (1) At least 4 weeks since the last dose of temozolomide; (2)At least 6 weeks since the last dose of lomustine or other nitrosoureas; (3)At least 2 weeks since the last dose of a small-molecule targeted agent (tyrosine kinase inhibitor or similar agent); (4)At least 12 weeks since the last dose of bevacizumab or any other vascular endothelial growth factor (VEGF) antibody-based therapy; 11. If the patient is receiving corticosteroids, the corticosteroid dose must have been stable or reduced to a dexamethasone-equivalent dose of =6 mg/day for at least 7 days before enrollment; 12. Adequate organ and bone marrow function within 14 days before enrollment, meeting the following laboratory requirements: (1) International normalized ratio (INR) =100 × 10^9/L; (3)Serum creatinine (Scr) =1.5 × 10^9/L; (5) Hemoglobin (Hb) >=90 g/L. 13. For women of childbearing potential, a negative pregnancy test within 14 days before enrollment; 14. Male participants or non-pregnant women of childbearing potential must agree to use medically acceptable contraception; 15. Inclusion criteria after angiographic evaluation: 15.1. Neurovascular anatomy requirement: Suitable vascular anatomy for microcatheter placement, ensuring that microcatheterization can be performed safely (at up to two positions), and that yttrium-90 microspheres can be infused into the T1-enhancing lesion area confirmed by the study team. 15.2. Treatment territory requirement: The treatment area must be located in a non-eloquent brain region, and the total treatment volume must not exceed 150 cc (including only the T1-enhancing region; non-enhancing necrotic areas within the tumor are excluded). Eloquent brain areas are defined as regions related to lan
Exclusion criteria
Exclusion criteria: (1) Tumor adjacent to or invading the brain stem; (2) Patients who had received two or more lines of systemic anti-tumor therapy, temozolomide maintenance therapy was not included in the number of treatment lines; (3) Received thoracic radiotherapy; An increased risk of wound dehistion, as judged by the investigator (e.g., brain surgery within the past 3 months, poor skin condition, and/or infection in the area of previous surgery, or any other condition considered by the neurosurgeon to increase the risk of infection); (4) Uncontrollable epilepsy; (5) With severe and/or inadequately controlled comorbidities; Patients were ineligible if they: 1) drug-poorly controlled hypertension grade 3 or higher; 2) symptomatic or unstable cardiac disease, known right-to-left shunt, or severe pulmonary hypertension (pulmonary arterial pressure >90 mmHg); 3) pulmonary insufficiency (Arterial partial pressure of oxygen (PaO2) = grade 1; 8) treat any other disease or condition that, in the opinion of the investigator, would interfere with adherence to the study or endanger patient safety, study endpoint, or life expectancy; (6) Being pregnant or breastfeeding (unless the patient agrees to stop breastfeeding); (7) Patients with a history of other active malignant tumors within 1 year before registration. Note: Exceptions to this requirement include adequately treated non-melanoma skin cancer or LM or carcinoma in situ with no evidence of disease, or recurrent glioblastoma; (8) Patients with a history of ischemic encephalopathy and/or risk of cerebral herniation; (9) Medical contraindications to enhanced Magnetic Resonance Imaging (MRI); (10) A known history of allergic reactions to iodine and/or gadolinium contrast media; (11) The study participant received any additional investigational drug within 4 weeks after treatment or was currently participating or planned to participate in another investigational trial that could affect the results of this trial (unless written approval was received from the Boston Scientific Research team); (12) Angiographic mapping exclusion criteria: patients with significant vascular disease, significant atrioventricular shunt, anatomical distortion on MR/CT angiography that prevented safe or feasible vascular access, or treatment plans with functional high-risk vascular distribution; (13) Patients had received radiation therapy such as seed implantation in the brain; (14) Patients with surgical opportunity as assessed by MDT, including limited tumor and maximally safe resection; The recurrent tumor is a solitary lesion, which can bring clinical benefit after resection. Patients with initial treatment of low-grade glioma, no evidence of progression and surgical indications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-related adverse events;Technical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;6-month survival rate; | — |
Countries
China
Contacts
Public ContactYang Xuejun
Beijing Tsinghua Changgung Hospital
Outcome results
None listed