Glioblastoma multiforme
Conditions
Interventions
exprimental group:Tumor Treating Fields + Temozolomide + tislelizumab
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. After brain surgery (patients with total resection, partial resection and biopsy were acceptable), the pathological examination confirmed glioblastoma with IDH wild-type according to the 2021 WHO classification of tumors of the central nervous system. 2. The age of the subjects was =18 years old; 3. Supratentorial tumors; 4. Patients who had undergone maximal surgical resection (biopsy) and completed TMZ concurrent chemoradiotherapy were planned for adjuvant TMZ treatment. 5. KPS score =70; 6. The predicted survival time was =3 months. 7. Voluntarily signed informed consent; 8. Subjects of childbearing potential had to agree to use effective contraception for the duration of the trial. Note: Women who were not of reproductive age were defined as those who had undergone surgical sterilization (including hysterectomy, bilateral oophorectomy, or total hysterectomy) or were postmenopausal (defined as those who had not had menses for more than 12 consecutive months without a medical reason).
Exclusion criteria
Exclusion criteria: 1. Early progression of GBM occurred after TMZ+RT treatment (except pseudoprogression, imaging examination should be supplemented to further exclude if necessary). 2. The subject had received any other cytotoxic or biologic antineoplastic therapy before enrollment; 3. Distant leptomeningeal metastasis; 4. Patients had a diagnosis of cancer other than glioblastoma and received antineoplastic therapy within 5 years before enrollment, excluding cured stage I prostate cancer, cervical or uterine cancer in situ, breast cancer in situ, and nonmelanoma skin cancer. 5. Previous treatment with anti-PD-1 antibody/anti-PD-L1 antibody and anti-CTLA-4 antibody; 6. Participants who had received systemic immunosuppressive therapy (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, or antineoplastic factor agents) within 2 weeks before enrollment. Excluding nasal sprays and inhaled corticosteroids; 7. The presence of an active, known, or suspected autoimmune disease that was judged by the investigator to be unsuitable for this study. The following exclusions may be made: vitiligo, alopecia, Graves' disease, psoriasis, or eczema that did not require systemic treatment within the previous 2 years; Hypothyroidism (due to autoimmune thyroiditis) that is asymptomatic or requires only stable doses of hormone-replacement therapy or type I diabetes that requires only stable doses of insulin-replacement therapy, or childhood asthma that has resolved completely without intervention or recurrence in adulthood without an external trigger. 8. Participants had to meet certain criteria for bone marrow, liver and kidney function before enrollment, and were not eligible if they had any of the following: a. Thrombocytopenia (platelet count 1.7 mg/dL, or >150 µmol/L). 9. The subject had an active implanted device (deep brain stimulator, spinal cord stimulator, vagus nerve stimulator, pacemaker, cardiac defibrillator, etc.). 10. Infratentorial tumors; 11. Documented increased intracranial pressure (clinically manifested as severe papilledema, vomiting, nausea, or decreased consciousness); 12. There were infection, ulcer and unhealed wound in the skin where the electrode was applied. 13. A known history of allergy to TMZ or tislelizumab; 14. Skull defects or residual metal fragments in the skull (except titanium plates or nails used for skull surgery); 15. Patients allergic to conductive hydrogels or medical adhesives; 16. Those who are pregnant or preparing to become pregnant or who are breastfeeding; 17. Patients with poor compliance, as judged by the investigator, or other factors considered by the investigator to be not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event;Objective response rate (ORR);Disease control rate (DCR);Overall Survival (OS);1-year OS rate;PFS rate at 6 months;PFS rate at 1 year; | — |
Countries
China
Contacts
Public ContactLiang Chen
Huashan Hospital affiliated to Fudan University
Outcome results
None listed