NCT05031533招募中不适用
A Prospective Study on the Efficacy, Safety and Immune Effects of Dose-painting Radiation for Locally Advanced Non-small Cell Lung Cancer(LA-NSCLC)
Sichuan Cancer Hospital and Research Institute4 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- FPS
研究概览
简要总结
The study evaluated the effectiveness, safety and immune effects of dose-painting radiation in patients with locally advanced non-small cell lung cancer.
详细描述
The study evaluated the effectiveness, safety and immune effects of dose-painting radiation in patients with locally advanced non-small cell lung cancer.
The primary endpoint is PFS. Secondary points contains ORR, OS, HRQoL, and safety.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient or the legal representative of the patient can sign a written informed consent, and can understand and agree to follow the research requirements;
- •The age at the time of signing the informed consent form is between 18 and 75 years old;
- •It is diagnosed as non-small cell lung cancer by histology, and is suitable for radical radiotherapy:
- •Stage II-Ⅲ (AJCC 8th edition [Rice et al., 2017]) inoperable NSCLC patients (not medically suitable for surgery or refuse surgical intervention);
- •Measurable lesions that meet the definition of RECISTv1.1;
- •ECOG physical status ≤ 2;
- •Survival expectancy ≥ 3 months;
- •Hemoglobin ≥100g/L, WBC≥4×109/L, platelet ≥100×109/L (or follow the standards of each center);
- •Liver function: ALT, AST<1.5 times the upper limit of normal (ULN), total bilirubin<1.5×ULN;
- •Renal function: serum creatinine <1.5×ULN;
- •Pulmonary function: FEV1>50%, the percentage of DLCO (lung diffusion function) measured value and predicted value>80% mild to moderate lung function impairment.
- •The patient has good compliance with the treatment and follow-up.
排除标准
- •There is evidence of distant metastasis (M1, AJCC 8th edition [Rice et al., 2017]);
- •There is pleural effusion, pericardial effusion or ascites that is not clinically controlled and requires repeated drainage or medical intervention (within 2 weeks before randomization);
- •Intolerance or resistance to the chemotherapy, targeted, and immunotherapy specified in the experimental protocol;
- •Have received radiotherapy and surgical treatment;
- •There were other active malignant tumors ≤ 2 years before enrollment, except for the specific cancers under study in this study and locally recurring cancers that have been cured (eg, resected basal cell or squamous cell skin cancer, superficial Bladder cancer, carcinoma in situ of the cervix or breast);
- •A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis, acute lung diseases, etc.;
- •Has suffered from other malignant tumors;
- •Subjects who have received other drug trials within the past month;
- •Pregnant or lactating women and women who refuse contraception during the treatment observation period;
- •People with a history of severe allergies or idiosyncratic physique;
- •Those with a history of severe lung or heart disease;
- •Refusal or inability to sign the informed consent to participate in the trial;
- •Drug or alcohol addicts;
- •Personality or mental illness, lack of capacity for civil conduct or limited capacity for civil conduct.
结局指标
主要结局
FPS
时间窗: up to 3 years
progression-free survival (PFS) refers to the time from enrollment to the first recording of disease progression as determined by RECISTv1.1, or to death due to any cause (whichever occurs first). PFS will be analyzed in the ITT analysis set.
次要结局
- HRQoL(up to 3 years)
- ORR(up to 3 years)
- OS(up to 3 years)
研究者
LI TAO
Researcher
Sichuan Cancer Hospital and Research Institute
研究点 (4)
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