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The goal of this clinical trial is To investigate the safety and efficacy of Tumor-Treating Fields (TTFields) in combined with temozolomide (TMZ) and tislelizumab in the treatment of newly diagnosed glioblastoma (GBM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor Treating Fields + Temozolomide + Tislelizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor Treating Fields | Device | Tumor Treating Fields will be administered continuously with a planned ≥ 18 h per day, starting on the Day 1 of cycle 1 (C1D1), throughout the entire course of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from the start of treatment until disease progression or death due to any cause, whichever occurs first | Up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Adverse events will be defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with study treatments | Up to 18 months |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
Early progression of GBM occurred after TMZ+radiation therapy (RT) treatment (except pseudoprogression, imaging examination should be supplemented to further exclude if necessary).
The subject had received any other cytotoxic or biologic antineoplastic therapy before enrollment;
Distant leptomeningeal metastasis;
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.
Previous treatment with anti-PD-1 antibody/anti-PD-L1 antibody and anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody;
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;
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.
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:
The subject had an active implanted device (deep brain stimulator, spinal cord stimulator, vagus nerve stimulator, pacemaker, cardiac defibrillator, etc.).
Infratentorial tumors;
Documented increased intracranial pressure (clinically manifested as severe papilledema, vomiting, nausea, or decreased consciousness);
There were infection, ulcer and unhealed wound in the skin where the electrode was applied.
A known history of allergy to TMZ or tislelizumab;
Skull defects or residual metal fragments in the skull (except titanium plates or nails used for skull surgery);
Patients allergic to conductive hydrogels or medical adhesives;
Those who are pregnant or preparing to become pregnant or who are breastfeeding;
Patients with poor compliance, as judged by the investigator, or other factors considered by the investigator to be not suitable for the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital affiliated to Fudan University | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Tislelizumab | Drug | Tislelizumab will be given 300 mg intravenously every 4 weeks beginning on Day 1 of Cycle 2 of adjuvant TMZ. The Tislelizumab treatment should be continued until confirmed PD, unacceptable toxicity, or finished Tislelizumab treatment for other reasons. |
|
| Temozolomide (TMZ) | Drug | The patients will carry out 6 cycles of TMZ adjuvant chemotherapy according to the instructions. The dosage of TMZ is 150-200 mg/(m2·d), daily for 5 days followed by 23 days without treatment, the treatment cycle is 28 days. The initial dose of cycle 1 is 150 mg/(m2·d), if patients do not experience TMZ chemotherapy toxicity, the dose should be increased to 200 mg/(m2·d) in subsequent treatment cycles. After 6 cycles of TMZ adjuvant chemotherapy, if the patients do not experience disease progression, it is recommended to continue TMZ adjuvant chemotherapy, or treated according to investigators' recommendations. The TMZ treatment should be continued until confirmed progressive disease (PD), unacceptable toxicity, or finished TMZ treatment for other reasons. |
|
ORR is defined as the number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR).
| Up to 18 months |
| Disease control rate (DCR) | DCR is defined as the rate of best objective response of CR, PR, or stable disease (SD) | Up to 18 months |
| Overall Survival (OS) | OS is defined as the time from the date of treatment until death due to any cause | Up to 18 months |
| PFS rate at 6 months | The analysis will be estimated proportions of patients who are progression-free at 6 months following the time of enrollment | Up to 6 months |
| PFS rate at 1 year | The analysis will be estimated proportions of patients who are progression-free at 1 year following the time of enrollment | Up to12 months |
| OS rate at 1-year | The analysis will be estimated proportions of patients who are survival at 1 year following the time of enrollment | Up to12 months |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |