A Phase II/III Clinical Trial With Ex Vivo Expanded Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of tumor size
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of ex vivo expanded autologous immune killer cells in treating hepatocellular carcinoma patients in：
- Reduction of tumor size
- Reducing the relapse rate: Reducing the frequency of TACE treatment by IKC injections.
详细描述
This is a phase II/III clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce the patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of twelve infusions.
60 patients are anticipated to be recruited. This is a double-arm study, the experimental group will receive IKC treatment along with TACE treatment. The control group will receive only TACE treatment. 30 patients will be randomized into each arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign and give written informed consent.
- •Age≧20 years, but<80 years.
- •Hepatocellular carcinoma by CT, MRI, AFP, angiography or cytology/biopsy examinations.
- •Barcelona staging system stage B and C.
- •Never receive TACE treatment and comply with the standard of TACE treatment.
- •Child-Pugh stage A and B.
- •ECOG performance status 0 to 2.
排除标准
- •Participant of other clinical trial within the past 4 weeks of screening period.
- •Receiver of chemotherapy, radiotherapy, immunotherapy, hormone therapy, local tumor therapy, or target therapy within the past 4 weeks of screening period.
- •Carriers of HIV or HTLV within the past 4 weeks of screening period.
- •With Active acute or chronic infection by (investigator's judgement).
- •Other diseases, except hepatocellular carcinoma, which are life-threatening to the patients (by investigator's judgement) for example:
- •5.1 Active cardiac disease requiring therapy for coronary artery disease, congestive heart failure, arrhythmia or myocardial infarction.
- •5.2 With previous history of encephalopathy within the past six months.
- •5.3 Involved Involving systemically or known central nerve system diseases(brain or meningeal metastasis).
- •Women of pregnant or breast-feeding or child-bearing potential but without adequate contraception.
结局指标
主要结局
Change of tumor size
时间窗: One year
Evaluate the efficacy of autologous immune killer cells using Response Evaluation Criteria in Solid Tumors (RECIST) by recording net changes of tumor sizes
Progression-Free Survival (PFS)
时间窗: One year
The length of time during and after the treatment of a disease, that a patient lives with the disease but it does not get worse
次要结局
- Improvement of immune responses(One year)