NCT02018757Unknown2 期
Clinical Application Study of Transarterial Chemoembolization Containing Arsenic Trioxide in the Treatment of Hepatocellular Carcinoma
First Hospital of China Medical University5 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 250
- 试验地点
- 5
- 主要终点
- time to progression
研究概览
简要总结
The purpose of the study is to determine whether transarterial chemoembolization containing arsenic trioxide is safe and effective in the treatment of intermediate-stage hepatocellular carcinoma.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •accordance with primary hepatocellular carcinoma diagnosis standard：cytohistology standard or non-invasive standard.1）+2）a or 1）+2）b+3）of the following are the non-invasive diagnosis criteria:(1)patients with HBV or HCV related liver cirrhosis.(2)radiological lesion(s) in liver with arterial hypervascularity and venous or delayed phase washout: a.one kind of imaging technology diagnosis for those with lesions>2cm;b.two kinds of imaging technology obtains the consistent conclusion for lesions with diameter of 1-2 cm.(3)serum AFP level ≥400 ug/L lasting for more than 1 month or ≥200 ug/L lasting for more than 2 months, other diseases that may cause the AFP level increase can be excluded,such as pregnancy, genital or embryonic tumors and active hepatitis.
- •age of 18 to 75 year,male or female
- •life expectancy of 12 weeks
- •Barcelona Clinic Liver Cancer (BCLC)stage B
- •laboratory tests:(1)leukocyte>3*19^9/L;(2)hemoglobin≥8.5g/dl;(3)platelet count ≥50*10^9/L,(4)ALT and AST were less than three times the normal limit;(5)albumin ≥ 3.0 g/dl;(6)total bilirubin acuities 3 mg/dl;(7)prothrombin time international standardization ratio (PT - INR) < = 2.3 or prothrombin time (PT)more than normal compared 3 seconds;(8)serum creatinine is less than 1.5 times the normal of the upper limit
- •patients with signed informed consent
排除标准
- •concomitant malignancies distinct from HCC currently or previously
- •allergic to subject agent(such as arsenic) or other agent related to the trial
- •BCLC stage 0,A,C or D
- •HCC accounting for the 70% of the liver size or more
- •liver function Child-Pugh score of C
- •ECOG score of 1 or higher
- •severe heart diseases,such as congestive heart failure with cardiac function of New York Heart Association(NYHA)functional class II or severe, active coronary disease(except for who with myocardial infarction for more than 6 months) and cardiac arrhythmia needing medical management(except for that controllable by β-blockers、calcium channel blockers and digoxin )
- •uncontrollable hypertension(diastolic blood pressure cannot be controlled below 90 mmHg even after antihypertension treatment by antihypertensive drugs).
- •active severe infection(grade 2 or higher according to NCI-CTCAE version 4.0)
- •active tuberculosis or pulmonary tuberculosis cannot be excluded
- •CNS malignancies, including intracranial metastases
- •gastrointestinal bleeding with clinical findings in the previous 30 days
- •chronic renal failure
- •pregnancy or breastfeeding
- •any other unstable conditions or circumstances possibly to jeopardise the safety or compliance of the subjects.
研究组 & 干预措施
As2O3
Experimental
Subjects will be treated with TACE containing As2O3
干预措施: TACE containing As2O3 (Drug)
placebo
Placebo Comparator
Subjects will be treated with TACE containing placebo which mimics the arsenic trioxide
干预措施: TACE containing placebo (Drug)
结局指标
主要结局
time to progression
时间窗: From date of randomization until the date of first documented progression, up to 24 months
次要结局
- objective response rate(every 3 months from randomization until the date of first documented progression, up to 24 months)
- Proportion of Participants with Adverse Events(every 3 months from randomization until the date of first documented progression, up to 24 months)
- progression free survival(From date of randomization until the date of first documented progression, up to 24 months)
- overall survival(From date of randomization until the date of death from any cause, up to 60 months)
研究者
Haibo Shao
Professor
First Hospital of China Medical University
研究点 (5)
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