NCT04522687招募中不适用
Observation of the Impact of Radiotherapy With or Without Chemotherapy in the Value of Peripheral Blood Lymphocyte Subsets for Patients With Thoracic Cancer
Shanghai Cancer Hospital, China1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2012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
- 500
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This study is an observation, single center study to evaluate the alternations and prognostic value of peripheral blood lymphocyte (PBL) in patients diagnosed with thoracic cancers, including lung cancer, esophageal squamous cell carcinoma and thymic epithelial carcinoma underwent radiotherapy with or without chemotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 18 years. ECOG PS 0-
- •Pathologically confirmed NSCLC, esophageal squamous cell carcinoma or thymic epithelial tumor.
- •Life expectancy of more than 3 months. Patients with no indications for palliative radiotherapy in the opinion of the investigator.
- •Patients with a prior history of surgery are eligible if they have recovered adequately from the toxicity and/or complications of surgery.
- •Signed informed consent for the use of fresh tumor biopsies before and during the treatment.
- •Women of childbearing age and men must agree to use effective contraception during the trial.
- •Adequate organ function within 1 week prior to the enrollment：
- •Adequate bone marrow function: hemoglobin ≥80g/L, white blood cell (WBC) count ≥ 4.0 * 10 ^ 9/L or neutrophil count ≥ 1.5 * 10 ^ 9/L, and platelet count ≥ 100 * 10 ^ 9/L;
- •Adequate hepatic function: total bilirubin < 1.5 x upper limit of normal (ULN). Note: If total bilirubin is > 1.5 x ULN, direct bilirubin must ≤ ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 ULN;
- •Adequate renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min;
排除标准
- •Pregnant or lactating women. History of any other malignancy. Patients in whom palliative radiotherapy is indicated in the opinion of the investigator.
- •Active infection, congestive heart failure, myocardial infarction within the 6 months prior to enrollment, unstable angina pectoris or cardiac arrhythmia.
- •Patients who have received tumor vaccine; or administration of live, attenuated vaccine within 4 weeks before the start of treatment.
- •Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.
结局指标
主要结局
Overall Survival
时间窗: Five years
OS was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.
次要结局
- Progression Free Survival(Five years)
研究者
Fan Min
MD. PhD
Shanghai Cancer Hospital, China
研究点 (1)
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