NCT05105815尚未招募早期 1 期
An Exploratory Study on the Safety and Effectiveness of Autoimmune Cell Therapy Sensitized With Liver Cancer Neoantigen in Patients With High Risk of Recurrence After Surgical Resection of Primary Hepatocellular Carcinoma
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- DFS
研究概览
简要总结
In this study, safety and effects of IPM001 vaccine on human hepatocellular carcinoma are going to be investigated, IPM001 is a neoantigen/tumor-specific antigen sensitized autoimmune cell injection
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
- •understand and voluntarily sign a written informed consent;
- •Age: from 18 to 75 years, No restriction on gender;
- •Patients must have primary hepatocellular carcinoma;
- •Clinical stage: stage Ia~III a;
- •Child-pugh score ≤7;
- •HLA-A02 and consistent with ≥1 NeoAg or ≥2 aeTSA peptide bank;
- •ECOG PS score: 0~2;
- •Laboratory values as follow:
- •White blood cell count ≥ 3×109/L; Neutrophils: more than 1.5 × 109/L; Hemoglobin: more than 85g/L; Platelets: more than 5 × 1010/L; Total bilirubin:≤2 × ULN; Serum AST(GOT) and ALT(GPT)≤2.5 × ULN; Albumin ≥3.0 g/dL (30 g/L); Serum creatinine: less than 1.5 × ULN; Coagulation time was basically normal, PT extension ≤4s; No serious cardiopulmonary disease;
- •Blood collection body weight: male > 50 kg, female > 45 kg;
- •No obvious hereditary diseases;
- •Expected survival: more than 6 months;
排除标准
- •Patient has known distant organ metastasis;
- •Suffer from lymphoma or leukemia or MDS (myelodysplastic syndrome), etc.;
- •Woman be pregnant or lactating;
- •Suffer from mental or neurological diseases that are resistant to control;
- •The investigator judges that it is not suitable to participate in this clinical research (such as poor compliance, etc.);
- •Patients infected with human immunodeficiency virus (commonly known as AIDS) or Treponema pallidum (commonly known as syphilis);
- •Patients with a history of other malignant tumors in the past 5 years;
- •Organ transplantation or Myelosuppression;
- •History of drug abuse or alcohol abuse;
结局指标
主要结局
DFS
时间窗: 18 months
The time between the NeoAg/aeTSA CTL initiation and the onset of tumor recurrence or death from any cause
次要结局
- EORTC-QLQ30(18 months)
- OS(24 months)
研究者
研究点 (1)
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