NCT03124498Unknown1 期
A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of Autologous Cytokine-Induced Killer (CIK) Cell for Patients With Hepatocellular Carcinoma (HCC) After Transarterial Chemoembolization (TACE), Percutaneous Ethanol Injection Therapy (PEIT) or RadioFrequency Ablation (RFA) Therapy
Chuan An Biotechnology Co., Ltd.0 个研究点目标入组 55 人开始时间: 2017年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 55
- 主要终点
- Phase I: Presence or absence of Dose-Limiting Toxicity
研究概览
简要总结
A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of Autologous Cytokine-Induced Killer (CIK) Cell for Patients with Hepatocellular Carcinoma (HCC) after Transarterial Chemoembolization (TACE), Percutaneous Ethanol Injection Therapy (PEIT) or RadioFrequency Ablation (RFA) Therapy.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 to 80 years old men and women;
- •HCC diagnosed with typical imaging findings, or confirmed by needle liver biopsy;
- •Patients who are not a transplant candidate;
- •Patients who have no extrahepatic metastasis and are with measurable residual tumor after TACE, PEIT or RFA therapy;
- •Patients who have a life expectancy of at least 6 months;
- •Child-Pugh Class should be A or B;
- •Eastern Cooperative Oncology Group (ECOG) performance status score was 0-3;
- •Patients who have clinical laboratory test results as follows:
- •Absolute neutrophil count ≥ 1,500/µL or White blood cell ≥ 4,000/µL
- •Hemoglobin ≥ 8.5 g/dL
- •Platelet count ≥ 50,000/µL
- •Blood creatinine ≤ 1.5 x upper limit of normal
- •Total bilirubin < 3 x upper limit of normal
- •Albumin ≥ 2.8 g/dL
- •International normalized ratio (INR) / Partial thromboplastin time (PTT) < 1.5 x upper limit of normal
- •Written informed consent.
排除标准
- •Patients who have infiltrative or diffuse HCC;
- •Patients who have significant cardiovascular disease such as myocardial infarction occurred within recent 6 months, chronic heart failure or unstable coronary artery disease;
- •Patients who plan to receive systemic chemotherapy or target therapy;
- •Patients with other malignant tumor within the past 5 years before treatment;
- •Pregnant or lactating patients;
- •Patients with hemorrhage/bleeding event;
- •Patients with uncontrolled infections;
- •Known or suspected allergy to the investigational agent or any agent given in association with this trial;
- •Patients who have current Human Immunodeficiency Virus (HIV) or Treponema Pallidum (TP) infection;
- •Patients who are suffering from serious autoimmune disease;
- •Patients who have had long term use of or are using an immunosuppressant;
- •History of organ transplant;
- •Prior use of any anti-cancer treatments within 30 days or 5 half-lives (whichever is longer), except TACE, PEIT and RFA therapy;
- •Patients who have participated in another clinical study and received treatment within 30 days prior to the screening visit;
- •Mental conditions rendering the patient incapable of understanding the nature, scope, and consequences of the study;
- •Other situations that the researchers considered unsuitable for this study.
结局指标
主要结局
Phase I: Presence or absence of Dose-Limiting Toxicity
时间窗: 5 Weeks
Phase II: Disease Control Rate
时间窗: 24 Weeks
次要结局
未报告次要终点
研究者
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