NCT01749865已完成3 期
A Randomized Controlled Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients With Hepatocellular Carcinoma Who Underwent Radical Resection
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2008年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time to recurrence
研究概览
简要总结
This is a randomized controlled study. About 200 patients with hepatocellular carcinoma who underwent radical resection will be included. The patients will be randomized to group A (receive CIK treatment) or group B (just regularly follow up) without any anti-cancer treatment after resection of HCC, and the randomize ratio will be 1:1.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients over 18 years of age.
- •Without any prior anti-cancer therapy.
- •Patients who have a life expectancy of at least 12 weeks.
- •Patients already had radical resection of HCC.
- •Definition of radical resection in this study:
- •All tumors were moved out, with a clean resection margin.
- •Number of tumors less than
- •Without tumor invasion of the main trunk and first branch of the portal vein, or hepatic duct, or hepatic vein.
- •No hepatic hilum lymphnode metastasis.
- •No distance metastasis.
- •Hepatocellular carcinoma with histological diagnose.
- •No major post-operative complication.
- •Patients who have an performance status of 0, or
- •Cirrhotic status of Child-Pugh class A only.
- •The following laboratory parameters:
- •Patients who give written informed consent.
排除标准
- •Previous or concurrent cancer that is distinct in primary site or histology from HCC.
- •History of cardiac disease.
- •Active clinically serious infections ( over grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events version 3.0)
- •Known history of human immunodeficiency virus (HIV) infection
- •Known Central Nervous System tumors including metastatic brain disease.
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- •History of organ allograft.
- •Known or suspected allergy to the investigational agent or any agent given in association with this trial.
- •Pregnant or breast-feeding patients.
- •Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
- •Excluded therapies and medications, previous and concomitant:
- •Prior use of any anti-cancer treatment for HCC, eg. chemotherapy, radiotherapy. Antiviral treatment is allowed.
研究组 & 干预措施
B, CONTROL
No Intervention
Regular follow up with no intervention
A, CIK
Experimental
Biological/Vaccine: Cytokine-Induced Killer Cells
干预措施: Cytokine-Induced Killer Cells (Biological)
结局指标
主要结局
Time to recurrence
时间窗: 5-year
To evaluate efficacy of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection.
次要结局
- Disease Free Survival(5 year)
研究者
LI Sheng-ping
Vice director, Sun Yat-sen University Cancer Center
Sun Yat-sen University
研究点 (1)
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