NCT04654234已完成不适用
Total-body PET/CT Imaging Using the uEXPLORER in Non-small Cell Lung Cancer Patients Treated by Induction Chemotherapy Plus Nivolumab and Definitive Concurrent Chemoradiotherapy
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Patlak-Ki (Ki)
研究概览
简要总结
The prospective study aims to explore the value of total-body PET/CT dynamic imaging (uExplorer) in assessing tumor metabolic heterogeneity and predicting prognosis for patients with locally advanced, unresectable non-small cell lung cancer (stage III) treated by neoadjuvant chemotherapy plus nivolumab and definitive concurrent chemoradiation therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed, written and dated informed consent prior to any study specific procedures;
- •Patients aged 18~75 years old;
- •had histologically or cytologically confirmed non-small cell lung cancer;
- •Without prior chemotherapy, radiotherapy, surgery, targeted therapy or immunotherapy;
- •Life expectancy ≥12 weeks;
- •World Health Organization (WHO) Performance Status of 0 or 1;
- •had unresectable stage III disease according to the 8th edition of the American Joint Committee on Cancer staging system;
- •Women should be non-breast feeding during the study period;
- •Women of reproductive age (WOCBP) must agree to comply with the contraceptive method during the study treatment and for a period of 5 months following the last administration of the study treatment;
- •Men who have sex with WOCBP must agree to comply with the contraceptive method during the study treatment and for 7 months after the last administration of the study treatment;
- •Absolute neutrophil count ≥1500/uL, hemoglobin ≥9.0mg/dL, platelet ≥100000/uL;
- •Serum creatinine clearance >50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976);
- •Serum bilirubin ≤1.5 x upper limit of normal (ULN), Aspartate Transaminase(AST) and Alanine Transaminase(ALT) ≤2.5 x ULN;
- •Forced expiratory volume in 1 second (FEV1) ≥800ml;
排除标准
- •Concurrent enrollment in another clinical study, unless it is an observational(non-interventional) clinical study;
- •Mixed small cell and non-small cell lung cancer histology;
- •Prior exposure to any anti-programmed cell death protein(PD)-1 or anti- PD-L1 antibody;
- •Active or prior documented autoimmune disease within the past 2 years;
- •Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis);
- •History of primary immunodeficiency;
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses;
- •History of another primary malignancy within 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study;
- •Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control;
- •Any situation not suitable for this study judged by researchers;
结局指标
主要结局
Patlak-Ki (Ki)
时间窗: From enrollment to 1 year after radiotherapy
The prognostic role of Patlak-Ki and its dynamic change during treatment
次要结局
- standardized uptake value (SUV)(From enrollment to 1 year after radiotherapy)
- metabolic tumor volume (MTV)(From enrollment to 1 year after radiotherapy)
- total lesion glycolysis (TLG)(From enrollment to 1 year after radiotherapy)
研究者
Hui Liu
Clinical Professor
Sun Yat-sen University
研究点 (1)
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