A Prospective Cohort Study of Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 374
- 试验地点
- 5
- 主要终点
- Incidence of hyperprogression
研究概览
简要总结
Immune checkpoint inhibitors have ushered in a new era of cancer treatment, bringing significant survival benefits to patients. However, some patients have accelerated tumor growth in the early stage of immunotherapy, called hyperprogression. The quality of life of patients with hyperprogression is seriously reduced, and there is no effective treatment at present, and the prognosis is extremely poor. Therefore, early identification of high-risk groups of hyperprogression is the key to prevent hyperprogression. However, there are no effective biomarkers to predict hyperprogression. By sequencing, proteomics and metabolomics analysis of clinical tissue and blood samples, we found that the level of SAA1 was significantly increased in patients with hyperprogression, and SAA1 was an effective marker for predicting hyperprogression in pan-cancer. We planned to conduct a multicenter, prospective cohort study to verify the reliability of SAA1 as a marker for predicting hyperprogression of immunotherapy in pan-cancer 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
- •Over 18 years of age
- •Voluntarily sign informed consent
- •The pathological diagnosis was nasopharyngeal carcinoma, head and neck tumor, lung cancer, breast cancer, stomach cancer, colorectal cancer, glioma, esophageal cancer, liver cancer, bile duct cancer, cervical cancer, prostate cancer, bladder cancer and other malignant tumors
- •Need to be treated with immune checkpoint inhibitors
- •ECOG PS Score: 0/1.
排除标准
- •There are contraindications to immunotherapy
- •Combined with other tumors (basal cell or squamous cell skin cancer that has been cured, and cervical cancer in situ removed) External)
- •Patients had any serious coexisting medical conditions that could pose an unacceptable risk or negatively affect trial adherence. For example, unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor disease status, uncontrolled diabetes (fasting blood glucose > 1.5 × ULN), and mental illness.
- •At the investigator's discretion, those who was not considered to be suitable for participation in the study.
结局指标
主要结局
Incidence of hyperprogression
时间窗: 2 years
Incidence of hyperprogression will be calculated.
次要结局
- Event-free survival(3 years)
- Progression-free survival(3 years)
- Overall survival(3 years)