NCT03614949进行中（未招募）2 期
Phase II Study of Stereotactic Body Radiation Therapy and Atezolizumab in the Management of Recurrent, Persistent, or Metastatic Cervical Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to see if treatment with atezolizumab and stereotactic body radiation therapy (SBRT) will improve the objective response rate (ORR) compared with atezolizumab alone in patients with recurrent, persistent, or metastatic cervical cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) ≤ 2 or Karnofsky Performance Status of ≥ 60
- •Participants must have recurrent, persistent, or metastatic cervical cancer, including squamous cell, adenocarcinoma, and adenosquamous histologies recurrent, persistent, or metastatic p16+ cell cancer of the vagina or vulva
- •Measurable disease per irRECIST
- •Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation
- •Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥10 mm (≥1 cm) with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam.
- •Must have at least 2 distinct lesions as documented by imaging studies within 4 weeks prior to randomization
- •Consent to biopsy of metastatic site or consent to retrieval of archival tissue
排除标准
- •Patients with known brain metastasis
- •Active autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:
- •Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study
- •Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
- •History of prior malignancy within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of > 90%), such as but not limited to, non-melanoma skin carcinoma, ductal carcinoma in situ, or stage I endometrioid uterine cancer, and others at the discretion of the Principal Investigator (PI)
- •Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF)-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study, with the following exceptions:
- •Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy)
- •Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency
研究组 & 干预措施
Combination Therapy
Experimental
Stereotactic body radiation therapy (SBRT) followed by atezolizumab, 1 week later.
干预措施: Stereotactic body radiation therapy (SBRT) (Radiation)
Combination Therapy
Experimental
Stereotactic body radiation therapy (SBRT) followed by atezolizumab, 1 week later.
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Up to 5 years
ORR by Immune-Modified Response Evaluation Criteria in Solid Tumors (irRECIST) criteria of SBRT and atezolizumab in the management of recurrent/persistent/metastatic cervical cancer. Complete Response (CR): Disappearance of all lesions; Partial Response (PR): ≥30% decrease in tumor burden, a in the absence of CR; Progressive Disease (PD): ≥20% increase in tumor burden; Stable Disease (SD): Neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.
次要结局
- Progression-free Survival (PFS)(Up to 5 years)
- Overall Survival (OS)(Up to 5 years)
研究者
研究点 (2)
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