NCT06054685进行中（未招募）不适用
A Study on the Association Between Body Composition and Survival in Digestive System Tumors and Immune Treatment Response
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年4月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Investigators intend to utilize clinical data from the Department of Oncology at Jiangsu Provincial People's Hospital to analyze changes in body composition in digestive system tumor patients before and after receiving anti-tumor drug treatment. Investigators aim to uncover the association between baseline body composition and overall/progression-free survival in patients with digestive system tumors. Additionally, Investigators plan to investigate the relationship between changes in body composition during anti-tumor drug treatment (chemotherapy and immunotherapy) and the prognosis of tumor 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged between 18 and 85 years old.
- •Patients with histologically confirmed digestive tract cancers, such as esophageal cancer, gastric cancer, small intestinal cancer, colorectal cancer, as well as pancreatic cancer, liver cancer, gallbladder cancer, etc.
- •Patients admitted for anti-tumor-related drug treatment.
- •Expected survival period of more than three months.
- •ECOG PS score: <
- •No severe psychological disorders, physical disabilities, dementia, Alzheimer's disease, pulmonary tuberculosis, HIV/AIDS, or other infectious diseases.
- •Patients must have sufficient organ and bone marrow function, meeting the following criteria:
- •Hematological criteria:
- •Hemoglobin (Hb) ≥ 90 g/L (without blood transfusion in the past 28 days). Absolute neutrophil count (ANC) ≥ 1.5×109/L. Peripheral blood monocytes > 1500mm
- •Platelet count (PLT) ≥ 100×109/L.
- •Biochemical criteria:
- •Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN). ALT and AST ≤ 2.5×ULN; if there is liver metastasis, ALT and AST ≤ 5×ULN. Creatinine (Cr) ≤ 1.5×ULN or creatinine clearance rate (CCr) ≥ 60 ml/min (Cockcroft-Gault formula).
- •Coagulation function is sufficient, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN.
- •Women of childbearing potential must have a negative pregnancy test (serum or urine) within seven days before enrollment and must voluntarily use appropriate contraception methods during the observation period and within six months after the last dose.
- •Signed informed consent.
排除标准
- •Female patients who are pregnant or breastfeeding.
- •Patients with accompanying diseases, as judged by the investigator, pose a serious risk to patient safety or may affect the patient's ability to complete the study.
- •Patients with poor compliance who refuse to undergo body composition measurements.
- •Patients who experience a severe adverse event judged by the investigator as no longer suitable for continued participation in the study or those who become unexpectedly pregnant.
- •Patients who are unwilling to continue in the clinical trial and insist on withdrawal.
- •The investigator deems it necessary to terminate the study.
- •Patients who were mistakenly included but did not meet the criteria.
结局指标
主要结局
PFS
时间窗: 2025-01-30
Progress free survival
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer (MetaCa2)Hormonal TherapyBreast CancerNCT02509871Centre Jean Perrin33
已完成
不适用
Body Composition: a Predictor of Mortality in Subjects Over 65 YearsExternal Causes of Morbidity and MortalityNCT01472679Genton Graf Laurence6,000
招募中
Unknown
Body composition analysis by InBodyS10 and perioperative management of cardiovascular surgerycardiovascular diseaseJPRN-UMIN000049927St Marianna University School of Medicine200
Unknown
不适用
(Mol-SHARE) Molecular Study of Health Assessment and Risk in Ethnic GroupsCardiovascular DiseasesType 2 Diabetes MellitusInsulin ResistanceNCT00249314Hamilton Health Sciences Corporation120
已完成
不适用
Body Composition Post Cancer TreatmentCancerNCT03690401Prisma Health-Upstate52