Clinical Study for Combined Analysis of CTC and Exosomes on Predicting the Efficacy of Immunotherapy in Patients With Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- CTC-PD-L1, exosomal PD-L1, and exosomal LAG-3
研究概览
简要总结
This project intends to perform CTC PD-L1 imaging, exosomal PD-L1 protein detection, and exosomal LAG-3 protein detection, so as to resolve the functional marker profiles of immunotherapy in the peripheral blood of HCC patients and comprehensively present the responsiveness of patients to immunotherapy.
详细描述
Liquid biopsy methods such as PD-L1 of CTC, number of peripheral immune cells and their subtypes, and exosomal PD-L1 provide a dynamic monitoring strategy for immunotherapy evaluation. Monitoring CTC and immune-related functional markers in peripheral blood can dynamically reflect the multi-dimensional characteristics of tumor microenvironment, comprehensively represent the response of patients to immunotherapy, and provide a new strategy of companion diagnostics for immunotherapy in HCC. This project intends to perform CTC PD-L1 imaging, exosomal PD-L1 protein detection, and exosomal LAG-3 protein detection, so as to resolve the functional marker profiles of immunotherapy in the peripheral blood of HCC patients and comprehensively present the responsiveness of patients to immunotherapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having signed informed consent
- •clinically or pathologically confirmed hepatocellular carcinoma;
- •liver tumor load not exceeding 50% of liver volume;
- •expected survival ≥ 12 weeks;
- •vital organ function meeting enrollment criteria; and (6) no need for pregnancy.
排除标准
- •Patients who have been diagnosed with malignant tumors of other systems or organs;
- •Patients with hematologic disorders and extreme physical failure;
- •Patients with immune deficiencies or organ transplants;
- •Other conditions deemed by the investigator to be inappropriate for participation in this study.
结局指标
主要结局
CTC-PD-L1, exosomal PD-L1, and exosomal LAG-3
时间窗: Treatment baseline; Up to 2 months from the initial treatment; From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
次要结局
未报告次要终点