NCT02725996Unknown2 期
By Using Adoptive Transfer of Autologous NK Cells to Prevent Recurrence of Hepatocellular Carcinoma After Curative Therapy
Southwest Hospital, China1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2016年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Overall Survival(OS) :Overall survival was measured from the date of randomization until death from any cause.
研究概览
简要总结
To prove that the efficacy and safety of 'NK group' is superior to 'non-treatment group(Control group)' in patient undergone curative resection(RFA or operation) for hepatocellular carcinoma in China.
详细描述
No adjuvant therapy has been shown to extend the survival of patients with hepatocellular carcinoma receiving curative treatment.We investigated whether injections of NK cells prolongs recurrence-free survival of patients after curative therapy.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior to the test, patient is fully explained about the purpose/ contents and characteristics of the testing medication, and the patient him(her)self, the guardian or the legal representative signed on written consent.
- •Gender unlimited, age from 18 years to 70 years
- •The patient is diagnosed as hepatocellular carcinoma by pathological/ radiological test and he (she) is in the stage of I or II. (refer to the attached file 10). Hepatocellular carcinoma should be shown by radiological test; on dynamic CT, dynamic MRI or on angiography.
- •Child-Pugh Score should be less than 6
- •No matter how the patient has been treated before, his (her) tumor should be totally removed by curative resection (RFA or operation). (based on the agreement date for written consent)
- •Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
- •Patient's remaining life-time should be expected at least more than 3 months.
排除标准
- •Hepatocellular carcinoma has been transferred by pathological/ radiological test (Stage III or Stage IV, refer to the exhibit 10)
- •The carcinoma has been invaded to main portal vein or major branch hepatic vein
- •Child-Pugh score is over 6
- •Patient has serious problem with pulmonary function by sub- investigator's opinion
- •Patient who has disease history of immune deficiency
- •Diagnosed as an immune deficiency patient
- •Patient who has disease history of malignant tumor within 5 years before this clinical trial.
- •Patient who had anti-cancer medication before the clinical trial
- •Patient has serious allergic-history by sub- investigator's opinion
- •Patient has serious mental disease by sub- investigator's opinion
- •Pregnant women, nursing mother or having intention of being pregnant during the clinical test
- •Patient who participated in other clinical trial within 4 weeks before this clinical trial
- •Patient who is incongruent to this clinical trial by sub- investigator's opinion.
结局指标
主要结局
Overall Survival(OS) :Overall survival was measured from the date of randomization until death from any cause.
时间窗: 3 years
Recurrence Free Survival(RFS) :RFS was measured from the date of randomization to the first recurrence or to death from any cause.
时间窗: 3 years
次要结局
未报告次要终点
研究者
Zhi Yang
Researcher of Biotherapy Center
Southwest Hospital, China
研究点 (1)
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