Trajectory Analysis of Neutrophil to Lymphocyte Ratio（NLR） and Its Association With Efficacy of Immunochemotherapy in Esophageal Squamous Cell Carcinoma: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall survival and disease-free survival.
研究概览
简要总结
Conduct a retrospective and prospective study to confirm the association between blood cells counts and the efficacy and safety in immunochemotherapy in patients with advanced esophageal cancer.
详细描述
Studies have already demonstrated the feasibility of prognostic role of protein biomarkers change during the treatment trajectory of patients in several carcinoma,However, no study focused on the value of trajectory analysis of blood cells counts of Immunochemotherapy in patients with advanced esophageal cancer.
The investigators plan to analyze the dynamic change of blood cells counts longitudinally from preoperation to long term follow-up in advanced esophageal cancer and predict the efficacy and safety of immunochemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed esophageal squamous cell carcinoma
- •Potentially resectable esophageal squamous cell carcinoma at first diagnosis (cT1-4a N1-2 M0, cT3-T4a N0M0)
- •Treatment-naive
- •Expected life span > 6 months
- •Aged 18 - 75 years old
- •Adequate organ functions
- •Performance Status (PS) 0-2
- •Participants are fully informed about the whole study and are willing to sign the informed consent
排除标准
- •Previous history of thoracic surgery or radiation
- •Cervical or multi-origin esophageal cancer
- •Known or suspected experimental drug allergy
- •Pregnant or lactating women
- •Esophagomediastinal fistula
- •Peripheral neuropathy
- •Previous cancer history other than esophageal cancer
- •Severe organ function deterioration that can not tolerate neoadjuvant therapy
- •Previous autoimmune diseases
- •diabetic history > 10 years
- •interstitial pulmonary disease, non-infectious pulmonitis
- •Active type B hepatitis
- •Any other conditions that may affect patients' safety and compliance
结局指标
主要结局
Overall survival and disease-free survival.
时间窗: From the date of diagnosis to the date of death, assessed up to 100 months
Overall survival rate
次要结局
- Pathologic complete response rate(Three to five working days after surgery)
- Objective Response Rate (ORR)(Up to 24 weeks)
- Major pathological response(Three to five working days after surgery)
- Event-free survival(From the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months)
研究者
GuiBin Qiao
Professor of Medicine
Guangdong Provincial People's Hospital