Open-label, Single Center, Phase Ⅱ Clinical Trial to Evaluate Safety and Efficacy of Immuncell-LC in the Patients for Refractory Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- the disease control rate (DCR)
研究概览
简要总结
This study aims to evaluate the safety and efficacy of Immuncell-LC, the adoptive immuntherapeutic agent composed of a CIK cell agent, to treat patients with metastatic colorectal cancer, which are refractory to the 3rd-line chemotherapeutic agents.
All enrolled patients received the 12 times of Immuncell-LC therapy: 8 times in every 1 week and 4 times in every 2 weeks.
详细描述
Stage IV colorectal cancer(CRC) has poor survival rate in spite of the development of chemotherapeutic agents. It is regarded as a standard palliative chemotherapy using with both targeted agents and cytototic chemotherpeutic agents. However, it is still demanding to treat stage IV CRC patients, who are refractory responses in these chemotherapeutics. In addition, patients were suffered from the various adverse events by the repetive cytotoxic chemotherapies.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 19 years old
- •Clinical diagnosis of metastatic colon cancer or rectal cancer
- •Patients should meet below conditions by serologic test, kidney and liver function test: Re-evaluation is permitted during screening.
- •Absolute neutrophil count (ANC) ≥ 1500/μL
- •Hemoglobin level ≥ 9.0 g/dL
- •Platelet count >75,000/μL
- •BUN and serum Creatinine are less than or equal to 1.5 multiply normal upper-limit
- •AST and ALT are less than 2.5 multiply normal upper-limit (If a patients has liver metastases, AST and ALT are less than 5 times of normal upper-limits.)
排除标准
- •Patient who has disease history of immune deficiency or auto-immune disease (ex. Multiple sclerosis, arthritis rheumatism, Buerger's disease, and adolescent-occurred insulin dependent diabetes)
- •Pateint who diagnosed immune-deficiency diseases
- •Diagnosis of malignant tumor within 5 years before this clinical trial. (except for skin cancer, local prostate canter or carcinoma in situ of the cervix
- •Patient who needs interventional therapy due to intestinal obstruction of obstructive jaundice
- •Diagnosed status of infection or sepsis
- •Uncontrolled hypertension or heart-failure
- •Severe allergic history, which is diagnosed by sub-investigators
- •Serious psychologic disease, which is diagnosed by sub-investigators
- •Pregnant women, nursing mother or people who has intention of being preganant during the clinical test
- •Patient who participated in other clinical trials within last 4 weeks before this trial
结局指标
主要结局
the disease control rate (DCR)
时间窗: 4 months (17 weeks)
To evaluate the disease control rate (DCR) : complete reponse(CR), partial response(PR), stable disease(SD).
次要结局
未报告次要终点
研究者
Seung Hyuk Baik
Principal Investigator
Gangnam Severance Hospital