NCT01897610已完成2 期
Randomized, Open-label and Multi-center Clinical Trial to Evaluate the Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- To assess progression-free survival (PFS)
研究概览
简要总结
"Immuncell-LC" in aspects of therapeutic efficacy and safety when administered with Nexavar to advanced Hepatocellular carcinoma patients when compared with the control group who did not receive administration of the drug.
详细描述
- primary outcome Compare clinical efficacy of group treated with cell therapeutic Immuncell-LC evaluated by progression free survival with that of untreated group
- secondary outcome compare clinical efficacy of group treated with Immuncell-LC, a drug for treating advanced hepatocellular carcinoma evaluated by overall survival, disease control rate, changes of Alpha Feto Protein(AFP) figures from baseline to the last observation date and that of untreated group and evaluate adverse reactions, clinical pathological tests and its safety.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have consented to the study by providing signature of self, guardian or legal representative
- •The patient is more than 20 and less than 80 years old
- •The patient is diagnosed as hepatocellular carcinoma by pathological/radiological test and in the stage of III or IV
- •Child-Pugh Score should be A
- •ECOG Performance Status (ECOG-PS) is less than 2 or equal to
- •Patients who receiving or ready for Nexavar treatment
- •Patients who satisfy the following conditions of the blood test and kidney function test
- •Absolute granulocyte count is bigger than 1,000/µL
- •Hemoglobin is bigger than 8.5 g/dL
- •Platelet count is bigger than 5x10^10/L
- •Blood Urea Nitrogen(BUN) or Creatinine 1.5xupper normal limit
排除标准
- •Patients who are immune deficient or have a history of auto-immune diseases (Ex. Rheumatoid Arthritism, Systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-Dependent Diabetes Mellitus, etc.)
- •Patients who have a history of malignant tumors in the recent 5 years prior to the study with the exception of basal cell carcinoma, local prostate cancer, and cervical cancer, liver cancer.
- •Patients who had anti-cancer medication before the study with the exception of Nexavar
- •Patients who has serious dysfunction in other organs by sub-investigator's opinion
- •Patients has serious allergic-history by sub-investigator's opinion
- •Patients has serious mental disease sub-investigator's opinion
- •Pregnant women, nursing mother of having intention of being pregnant during the study
- •Patients who participated in other clinical trial within 4 weeks before this study
研究组 & 干预措施
Immuncell-LC group
Experimental
The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after baseline by administering Nexavar chemotherapy same as control group with Immuncell-LC (10 times).
干预措施: Immuncell-LC (Drug)
结局指标
主要结局
To assess progression-free survival (PFS)
时间窗: up to 2 years
CT, PET-CT, MRI
次要结局
- To assess the overall survival (OS)(up to 2 years)
- To evaluate the Disease control rate(up to 2 years)
- To assess the changes of Alpha Feto Protein(AFP)figures from baseline to the last observation date(up to 2 years)
- Number of participants with adverse events(up to 2 years)
研究者
研究点 (4)
Loading locations...
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