Recurrent Glioma
Conditions
Interventions
Test group 1:Sonodynamic Therapy for 10 mins, 100mg/day temozolomide (TMZ) dose and 200mg trastuzumab.
Test group 2:Sonodynamic Therapy for 20 mins, 100mg/day temozolomide (TMZ) dose and 200mg trastuzumab.
Test group 3:Sonodynamic Therapy for 30 mins, 100mg/day temozolomide (TMZ) dose and 200mg trastuzumab.
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–65 years, regardless of gender, with a Karnofsky Performance Status (KPS) score >=70 and an expected survival >=6 months. 2. Histopathologically confirmed WHO Grade 3 or 4 glioma, with disease recurrence after first-line treatment, assessed per the Response Assessment in Neuro-Oncology (RANO) criteria. 3. A single supratentorial, clearly measurable contrast-enhanced MRI lesion with a maximum diameter <=5 cm and a depth from the scalp <=8 cm. 4. Willingness to undergo the planned surgical procedure as per the study protocol. 5. Investigator-determined clinical benefit-risk assessment favoring participation in this trial. 6. Ability to understand and voluntarily sign informed consent, with commitment to comply with study and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Known allergy to hematoporphyrin-based drugs, any contraindications to MRI or ultrasound, or hypersensitivity to PD-1 inhibitors. 2. Diagnosis of immunodeficiency or ongoing systemic steroid therapy with dexamethasone >2 mg/day (or equivalent) or any other immunosuppressive treatment within 7 days prior to the first trial treatment. - Note: Low-dose corticosteroids (2 mg/day dexamethasone or equivalent) during screening may still be eligible if the dose is reduced to 2.5×ULN, total bilirubin > 1.5×ULN, serum creatinine > 1×ULN. - Coagulation abnormalities: - INR or PT > 1.5×ULN, APTT > 1.5×ULN. 6. Severe/uncontrolled cardiovascular, cerebrovascular, or pulmonary diseases, including: - Myocardial infarction, NYHA Class III-IV heart failure, >=Grade 2 heart block, severe arrhythmias, active asthma, or severe respiratory failure. 7. Uncontrolled infections or clinically significant active infectious diseases. 8. Immunocompromised patients** or those with positive syphilis (TP-Ab) or HIV serology. 9. History of other malignancies within 5 years (unless cured or adequately controlled, e.g., non-melanoma skin cancer). 10. Uncontrolled psychiatric disorders that may impair compliance or informed consent capacity. 11. Pregnant/lactating women or patients of childbearing potential unwilling to use effective contraception. 12. Other conditions deemed unsuitable by investigators, including: - Factors that may interfere with study results or participation (e.g., comorbidities, abnormal lab results, non-compliance).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| 36-Item Short Form Survey; | — |
Countries
China
Contacts
Public ContactFei Li
The First Hospital Affiliated to Army Medical University
Outcome results
None listed