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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06353360
Other study ID # HL-06
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date April 5, 2024
Est. completion date March 9, 2026

Study information

Verified date March 2024
Source Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date March 9, 2026
Est. primary completion date July 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. 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: 1. Thrombocytopenia (platelet count < 100×103/µL) 2. Neutropenia (absolute neutrophil count < 1.5×103/µL) 3. NCCI-CTCAE4 grade non-hematologic toxicity (except alopecia, nausea and vomiting) 4. Significant liver function impairment -AST or ALT exceeding 3 times the upper limit of normal 5. Total bilirubin more than 1.5 times the upper limit of the normal range 6. Severe renal impairment (serum creatinine >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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Tumor Treating Fields
Tumor Treating Fields will be administered continuously with a planned = 18 h per day, starting on the C1D1, throughout the entire course of treatment.
Drug:
Tislelizumab
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)
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 PD, unacceptable toxicity, or finished TMZ treatment for other reasons.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu Healthy Life Innovation Medical Technology Co., Ltd

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Objective response rate (ORR) ORR is defined as the number (%) of patients with at least 1 visit response of CR or PR. Up to 18 months
Secondary Disease control rate (DCR) DCR is defined as the rate of best objective response of CR, PR, or SD Up to 18 months
Secondary Overall Survival (OS) OS is defined as the time from the date of treatment until death due to any cause Up to 18 months
Secondary 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
Secondary 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
Secondary 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
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