NCT06353360招募中2 期
Tumor-Treating Fields (TTFields) in Combination With Temozolomide and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma: A Safety and Efficacy Clinical Study
Jiangsu Healthy Life Innovation Medical Technology Co., Ltd1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •After brain surgery (patients with total resection, partial resection and biopsy were acceptable), the pathological examination confirmed glioblastoma with isocitrate dehydrogenase (IDH) wild-type according to the 2021 World Health Organization (WHO) classification of tumors of the central nervous system.
- •The age of the subjects was ≥18 years old;
- •Supratentorial tumors;
- •Patients who had undergone maximal surgical resection (biopsy) and completed TMZ concurrent chemoradiotherapy were planned for adjuvant TMZ treatment.
- •Karnofsky performance status (KPS) score ≥70;
- •The predicted survival time was ≥3 months.
- •Voluntarily signed informed consent;
- •Subjects of childbearing potential had to agree to use effective contraception for the duration of the trial.
排除标准
- •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:
- •Thrombocytopenia (platelet count < 100×103/μL)
- •Neutropenia (absolute neutrophil count < 1.5×103/μL)
- •National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) 4 grade non-hematologic toxicity (except alopecia, nausea and vomiting)
- •Significant liver function impairment -aspartate aminotransferase (AST) or alanine transaminase (ALT) exceeding 3 times the upper limit of normal
- •Total bilirubin more than 1.5 times the upper limit of the normal range
- •Severe renal impairment (serum creatinine >1.7 mg/dL, or >150 μmol/L).
- •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.
研究组 & 干预措施
Tumor Treating Fields + Temozolomide + Tislelizumab
Experimental
干预措施: Tumor Treating Fields (Device)
Tumor Treating Fields + Temozolomide + Tislelizumab
Experimental
干预措施: Tislelizumab (Drug)
Tumor Treating Fields + Temozolomide + Tislelizumab
Experimental
干预措施: Temozolomide (TMZ) (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to 18 months
PFS is defined as the time from the start of treatment until disease progression or death due to any cause, whichever occurs first
次要结局
- PFS rate at 6 months(Up to 6 months)
- PFS rate at 1 year(Up to12 months)
- OS rate at 1-year(Up to12 months)
- Number of participants with adverse events (AEs)(Up to 18 months)
- Objective response rate (ORR)(Up to 18 months)
- Disease control rate (DCR)(Up to 18 months)
- Overall Survival (OS)(Up to 18 months)
研究者
研究点 (1)
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