NCT06463522招募中1 期
Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes Therapy in Patients With Hepatocellular Carcinoma
Beijing 302 Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This is a Phase 1, open label clinical trial of tumor-infiltrating lymphocytes for the treatment of patients with hepatocellular carcinoma. The purpose of this study is to assess the safety of tumor-infiltrating lymphocytes therapy in patients with hepatocellular carcinoma.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 70 years;
- •Diagnosis of HCC with BCLC stage B/C;
- •Anticipated survival time is longer than 3 months;
- •Liver function grade Child-Pugh A or B, without hepatic encephalopathy;
- •Left ventricular ejection fraction (LVEF) ≥ 50%;
- •ECOG physical status 0-2;
- •Laboratory tests at baseline meet the following: Absolute neutrophil count >1.0 x 109/L; Absolute neutrophil count >1.0 x 109/L; White blood cell count > 2.0 x 109/L; Platelet count > 60 x 109/L; Hgb > 8.0 g/dL; ALT and AST ≤ 5 times the upper limit of normal (ULN), Serum total bilirubin (TBiL) ≤ 51 mmol/L, or < 3 times the ULN.
- •Female subjects of childbearing potential must take acceptable measures to minimize the likelihood of pregnancy during the trial. Female subjects of childbearing potential must have a negative serum or urine pregnancy result within 48 hours prior to treatment;
- •Able to receive treatment and follow-up, including the need for the subject to receive treatment at the enrollment center.
排除标准
- •Pregnant or breastfeeding women;
- •WIth HIV/AIDS infection;
- •Active infection with a temperature >38.3°C prior to study treatment and have been treated with antibiotics within 2 weeks prior to enrollment;
- •Presence of the following pre-existing or concomitant diseases: Prior diagnosis of a severe autoimmune disease requiring systemic immunosuppression (steroids) for a prolonged period of time (more than 2 months), or immune-mediated symptomatic disease; Prior diagnosis of autoimmune-induced motor neuron disease; Prior toxic epidermal necrolysis release; Subjects with any psychiatric condition, including dementia, altered mental status, which may interfere with treatment in this study; Subjects with other malignancies in the previous 5 years; Subjects with heart failure ≥ grade 2 (NYHA) or hypertension uncontrolled by standard therapy; Subjects with unstable or active peptic ulcer or gastrointestinal bleeding; Subjects with serious uncontrollable disease, as determined by the study, that may interfere with treatment in this study;
- •Subjects undergoing treatment with systemic steroids;
- •Subjects who have previously used immune cell therapy (CIK, DC, DC-CIK, LAK therapy) and are less than 28 days from the end of treatment to screening;
- •Subjects who are allergic to cell therapy products or related drugs;
- •Subjects who have previously received an organ transplant or are planning to receive an organ transplant;
- •Subjects requiring anticoagulant therapy (warfarin or heparin);
- •Subjects who are judged by the investigator to be unsuitable for participation in this study due to other conditions.
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: day0, day3, week1, week2, week4, week12, week24
Safety and Tolerability of Autologous Tumor-infiltrating Lymphocytes Therapy
次要结局
- Concentration of Total Bilirubin (TBIL, mg/dL)(day0, day3, week1, week2, week4, week12, week24)
- Child-Turcotte-Pugh(CTP) score(day0, day3, week1, week2, week4, week12, week24)
- Quality of life of patients(day0, day3, week1, week2, week4, week12, week24)
研究者
研究点 (1)
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