A Randomized Controlled Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients With Hepatocellular Carcinoma Who Underwent Radical Resection.
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 (TTR)
研究概览
简要总结
Study hypothesis:
The recurrence rate of HCC patients after radical resection is about 60-70%. This study is based on the hypothesis that CIK treatment could decrease the recurrence rate by 15% to 20%.
Abstract:
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.
Study treatment:
Patients in group A will receive 4 cycles of CIK treatments within 3 months after their liver resection. Patients in group B will have no anti-cancer therapy. Anti-virus and other supportive therapies are available in both groups.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients > 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 <=
- •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 ECOG PS of 0, or
- •Cirrhotic status of Child-Pugh class A only.
- •The following laboratory parameters:
- •Platelet count >= 70 x 109/L
- •Hemoglobin >= 8.5 g/dL
- •Albumin >= 3.5 g/dL
- •Total bilirubin <= 25umol/L
- •Alanine transaminase (ALT) and AST <= 2.5 x upper limit of normal
- •Serum creatinine <= 1.5 x the upper limit of normal
- •Prothrombin time (PT) <= 3 seconds above control.
- •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 (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] 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 group)
regular treatment and follow up
A (CIK group)
cytokine-induced killer cell treatment plus regular treatment and follow up
干预措施: cytokine-induced killer cell (CIK) treatment (Biological)
结局指标
主要结局
Time to recurrence (TTR)
时间窗: month
次要结局
- Progression Free Survival (PFS)(month)
- Laboratory findings(every 3 months)
- AEs and SAEs(monthly)
- Overall survival (OS)(month)
研究者
LI Sheng-ping
Professor
Sun Yat-sen University