Cohort Studies of Impact of Pretreatment Emotional on Survival and the Predictive Role of Peripheral Blood Metabolic and Inflammatory Markers in Immunotherapy Response Among Treatment-Naïve, Advanced and Inoperable Gastroesophageal and Non-Small-Cell Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Cohort 1 & 2: Progression-free survival (PFS)
研究概览
简要总结
This is the prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC) and non-small-cell lung cancer (NSCLC).
详细描述
This is the prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable Gastroesophageal Cancer (GEC) and Non-Small-Cell Lung Cancer (NSCLC). Eligible patients were administered first-line treatment with either immune checkpoint inhibitor or a combination of immunotherapy and chemotherapy upon enrollment. This study will have 2 cohorts:
- Cohort 1: A prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable GEC patients.
- Cohort 2: A prospective, observational cohort study to explore the impact of pretreatment emotional distress on survival and the predictive role of peripheral blood metabolic and inflammatory markers in immunotherapy response among treatment-naïve, advanced and inoperable NSCLC patients.
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
- •Cohort 1 & 2
- •Inclusion Criteria:
- •Meet the diagnostic criteria for cancer (including esophageal, gastric, GEJ or NSCLC) through clinical, pathological, and imaging examinations;
- •Karnofsky Performance Status (KPS) score should be equal to or greater than 80 points;
- •Unresectable locally advanced or metastatic;
- •Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy);
- •Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1);
- •Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
- •Informed and agreed to participate in the study;
- •Required to complete the questionnaire independently or with assistance from others if needed;
- •Legal age, 18 years or older.
排除标准
- •Oncogene-driver positive;
- •Combined with other malignant tumors in the past 3 years;
- •Concurrent acute or chronic psychiatric disorders;
- •Current receiving anti-depressive or anti-anxiety therapy or other psychotropic drugs;
- •Previous treatment with other clinical drug trials;
- •Patients with symptomatic brain metastasis;
- •Severe intellectual disabilities or other communication difficulties that hindered normal interaction.
结局指标
主要结局
Cohort 1 & 2: Progression-free survival (PFS)
时间窗: 4 year
Time from the beginning of first-line immunotherapy to the first progression (PD) or death in patients
次要结局
- Value of Neutrophils to lymphocytes ratio (NLR)(0 day, 6 weeks)
- Value of eosinophil fraction(0 day, 6 weeks)
- Value of Platelet-lymphocyte ratio (PLR)(0 day, 6 weeks)
- Value of Monocyte-lymphocyte ratio (MLR)(0 day, 6 weeks)
- Value of Systemic immune inflammation index (SII)(0 day, 6 weeks)
- Value of Pan-immune inflammation value (PIV)(0 day, 6 weeks)
- Value of prognostic nutritional index (PNI)(0 day, 6 weeks)
- Value of Blood glucose(0 day, 6 weeks)
- Value of Triglycerides(0 day, 6 weeks)
- Value of Total cholesterol(0 day, 6 weeks)
- Value of Albumin(0 day, 6 weeks)
- Disease Control Rate (DCR)(1 year)
研究者
Huaidong Cheng
Professor
Anhui Medical University