Safety and Efficacy of Allogeneic NK Cells Therapy in Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
This is a multicenter, open-label, paired control study to evaluate the safety and clinical efficacy of allogeneic NK cells combined with targeted drug in the treatment for advanced HCC.
详细描述
Since killer cell immunoglobulin-like receptor (KIR) mismatch can inhibit the negative regulatory signal of autologous major histocompatibility complex (MHC) molecules and ensure sufficient NK cell activation, allogeneic NK cells therapy, as a potential therapeutic option for tumor, has achieved good results in patients with acute myeloid leukemia. In this study, investigators evaluate the safety and efficacy of allogeneic NK cells in the treatment of advanced HCC. 200 patients from three hospitals will be enrolled in this study and followed up for 1 year. Peripheral blood mononuclear cells (PBMCs) were isolated from patient-related donor and cultured in vitro for 15 days and infused to the patient in two consecutive days. Clinical data and laboratory data were collected and analyzed, including survival, impact indicators, hematology, biochemical indicators, and immunological indicators to evaluate the safety and efficacy of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •According to the 2010 edition of the diagnostic criteria for primary liver cancer BCLC, the patient was diagnosed as advanced hepatocellular carcinoma by pathology and imaging (BCLC C phase);
- •Child-Pugh A/B (5-9), Eastern Cooperative Oncology Group (ECOG) PS score less than 2 points;
- •Laboratory criteria:
- •Liver function: Child A/B, ALT < 200 U/L, AST < 200 U/L, Tbil <51μmol/L
- •Renal function: Creatinine clearance ≥ 60ml/minute
- •Hematologic function: PLT ≥40×10'9/L, WBC ≥2×10'9/L, HGB>80 g/L
- •Cardiac function: No abnormality in cardiac enzyme and ECG
- •Survival expectation is greater than 6 months;
- •Patients with active hepatitis B or C were treated with the appropriate NA or DAA medication, and all patients enrolled in the group were treated with targeted drugs.
- •The patient has a donor who meets the donor enrollment criteria and all patients and donors sign the Informed Consent Form;
排除标准
- •Women who are pregnant or breast-feeding.
- •Co-infected with hepatitis A, hepatitis E, AIDS or other infectious diseases.
- •Patients with serious complications such as acute infection and gastrointestinal bleeding within 30 days.
- •Patients with other serious systemic and psychiatric diseases.
- •Exposure to any cell therapy such as, but not limited to CIK, DC, CTL , PD-1 and stem cells therapy 6 months prior to study drug administration.
- •Other conditions that researchers believe may increase the risk of subjects or lead to affected study results, such as the presence of mental illness in subjects.
结局指标
主要结局
Incidence of Adverse Events
时间窗: From the date of enrollment to the end of two years of follow-up.
Incidence of Treatment-Emergent Adverse Events as assessed by \[National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0\]
Overall survival
时间窗: From the date of enrollment to the end of two years of follow-up.
Overall Survival (OS) defined as the time from randomisation until death by any cause. Participants will be followed up for survival follow up for at least five years.
次要结局
- Disease control rate(From the date of enrollment to the end of two years of follow-up.)