The Clinical Value of Peripheral Blood T Lymphocyte PD-1 Expression and T Cell Subset Distribution in the Immunotherapy of Advanced Primary HCC Patients.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Compare Progression Free Survival (PFS) Regimen using RECIST 1.1.
研究概览
简要总结
Providing more theoretical basis for the prediction of the efficacy of advanced HCC and helping select better advantaged population of HCC immunotherapy to maximize the benefits of patients By exploring the relationship between the changes of PD-1 expression in peripheral blood T lymphocytes and the clinical efficacy before and after the use of PD-1 / PD-L1 inhibitors.
详细描述
Exploring the expression of peripheral blood T lymphocyte PD-1 from an immunological perspective as a potential reference marker for selecting immunotherapy in advanced HCC patients, and elucidating the relationship between the level of peripheral blood T lymphocyte PD-1 expression and survival outcomes after receiving immunotherapy. Additionally, investigating whether there is consistency between the expression levels of PD-1 and PD-L1 and their impact on patients. Furthermore, exploring the correlation between the distribution of T cell subsets and the efficacy of immunotherapy to provide new theoretical evidence for the selection of target populations for immunotherapy and new clinical screening indicators for patient prognosis assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to participate in the clinical study, fully understand and be informed about the study, and sign the informed consent form;
- •Age between 18 and 75 years, male or female;
- •Strictly meet the clinical diagnostic criteria for hepatocellular carcinoma (HCC), confirmed by histology or cytology, with at least one lesion meeting the RECIST 1.1 criteria on CT or MRI examination;
- •No prior targeted therapy, immunotherapy, or systemic chemotherapy for liver cancer before admission;
- •Child-Pugh A liver function; Barcelona Clinic Liver Cancer (BCLC) stage B or C;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Normal function of major organs;
- •Expected survival time of at least 12 weeks or more.
排除标准
- •Patients who have not previously received treatment with Sintilimab or any other PD-L1 or PD-1 antagonist;
- •Patients with any active autoimmune disease or a history of autoimmune disease, or a history of immunodeficiency;
- •Patients requiring the use of immunosuppressive drugs;
- •Known history of allergy to the formulation of Sintilimab or any other component of the antibody formulation;
- •Patients with other malignant tumors.
研究组 & 干预措施
Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy
Any first-line treatment that includes immunotherapy、 Chemotherapy and Anti-angiogenesis Therapy
干预措施: Sintilimab (Drug)
结局指标
主要结局
Compare Progression Free Survival (PFS) Regimen using RECIST 1.1.
时间窗: 24 months
PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.
次要结局
未报告次要终点
研究者
Xin-Hua Xu
professor
China Three Gorges University, Yichang, China