TTField in Combination With Temozolomide and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma.

Inclusion Criteria:

1. After brain surgery (patients with total resection, partial resection and biopsywere acceptable), the pathological examination confirmed glioblastoma withisocitrate dehydrogenase (IDH) wild-type according to the 2021 World HealthOrganization (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 TMZconcurrent chemoradiotherapy were planned for adjuvant TMZ treatment.

5. Karnofsky performance status (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 forthe duration of the trial.

Exclusion Criteria:

1. Early progression of GBM occurred after TMZ+radiation therapy (RT) treatment (exceptpseudoprogression, imaging examination should be supplemented to further exclude ifnecessary).

2. The subject had received any other cytotoxic or biologic antineoplastic therapybefore enrollment;

3. Distant leptomeningeal metastasis;

4. Patients had a diagnosis of cancer other than glioblastoma and receivedantineoplastic therapy within 5 years before enrollment, excluding cured stage Iprostate cancer, cervical or uterine cancer in situ, breast cancer in situ, andnonmelanoma skin cancer.

5. Previous treatment with anti-PD-1 antibody/anti-PD-L1 antibody and anti-cytotoxicT-lymphocyte-associated protein 4 (CTLA-4) antibody;

6. Participants who had received systemic immunosuppressive therapy (including but notlimited 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 bythe investigator to be unsuitable for this study. The following exclusions may bemade: vitiligo, alopecia, Graves' disease, psoriasis, or eczema that did not requiresystemic treatment within the previous 2 years; Hypothyroidism (due to autoimmunethyroiditis) that is asymptomatic or requires only stable doses ofhormone-replacement therapy or type I diabetes that requires only stable doses ofinsulin-replacement therapy, or childhood asthma that has resolved completelywithout intervention or recurrence in adulthood without an external trigger.

8. Participants had to meet certain criteria for bone marrow, liver and kidney functionbefore enrollment, and were not eligible if they had any of the following:

9. Thrombocytopenia (platelet count < 100×103/μL)

10. Neutropenia (absolute neutrophil count < 1.5×103/μL)

11. National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) 4 grade non-hematologic toxicity (except alopecia, nausea and vomiting)

12. Significant liver function impairment -aspartate aminotransferase (AST) oralanine transaminase (ALT) exceeding 3 times the upper limit of normal

13. Total bilirubin more than 1.5 times the upper limit of the normal range

14. Severe renal impairment (serum creatinine >1.7 mg/dL, or >150 μmol/L).

15. The subject had an active implanted device (deep brain stimulator, spinal cordstimulator, vagus nerve stimulator, pacemaker, cardiac defibrillator, etc.).

16. Infratentorial tumors;

17. Documented increased intracranial pressure (clinically manifested as severepapilledema, vomiting, nausea, or decreased consciousness);

18. There were infection, ulcer and unhealed wound in the skin where the electrode wasapplied.

19. A known history of allergy to TMZ or tislelizumab;

20. Skull defects or residual metal fragments in the skull (except titanium plates ornails used for skull surgery);

21. Patients allergic to conductive hydrogels or medical adhesives;

22. Those who are pregnant or preparing to become pregnant or who are breastfeeding;

23. Patients with poor compliance, as judged by the investigator, or other factorsconsidered by the investigator to be not suitable for the study.