Clinical Trial of Transcatheter Arterial Chemoembolization With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas
试验速览
- 阶段
- 不适用
- 入组人数
- 2,840
- 试验地点
- 1
- 主要终点
- Time to progression
研究概览
简要总结
The purpose of the study is to evaluate the effects of Transcatheter Arterial Chemoembolization (TACE) with KMG microsphere in treating advance-stage Hepatocellular Carinoma(HCC).
详细描述
This is a prospective, multicentre, random, controlled clinical trial of Transcatheter Arterial Chemoembolization (TACE)with KMG Microsphere Treating Advance-stage Hepatocellular Carinomas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 是
入选标准
- •Hepatocellular Carinomas with diagnosis of pathology or cytology or consistent with China 2001 guideline of Clinical Diagnosis Hepatocellular Carinomas
- •clinical stage（The Barcelona Liver Clinic staging system,BCLC B and C)，or can not receive surgical intervention
- •liver function:Child-Pugh A、B
- •PST 0-1（Eastern Cooperative Oncology Group Performance Score ,ECOG）
- •Lifespan≥6 months
- •First time to receive treatment
- •Can accept the follow up
- •informed consent was gotten
- •the number of lesion ≤ 5
排除标准
- •pregnant or lactation woman
- •emotional disturbance
- •serious heart ,lung disfunction or serious diabetes mellitus
- •serious reactiveness infections;（exp:type B or C hepatitis）
- •liver function :Child-Pugh Score C
- •thrombocyte<6×109/L
- •diffuse HCC
- •widespread metastasis
- •serious atherosclerosis
- •acquired immunodeficiency syndrome;AIDS
- •thrombosis or thrombosis event in 6 months
- •renal inadequacy who need hemodialysis or peritoneal dialysis
- •with other tumors except basal cell carcinoma and carcinoma in situ of cervix
- •serious alimentary tract hemorrhage in 4 weeks
研究组 & 干预措施
TACE -oil
embolization agent:Iodinated Oil or /and gelatin sponge Iodinated Oil （5-30ml）with Epirubicin （30-40mg/m2） or and gelatin sponge
干预措施: Therapeutic Chemoembolization (Procedure)
TACE-KMG ( routine dose Chemo)
embolization agent:KMG microsphere( 150-450µm,0.2-2g) with routine dose Epirubicin （30-40mg/m2）
干预措施: Therapeutic Chemoembolization (Procedure)
TACE-KMG( low dose Chemo )
embolization agent:KMG microsphere( 150-450µm,0.2-2g) with low dose Epirubicin （5-10mg/m2）
干预措施: Therapeutic Chemoembolization (Procedure)
TACE-KMG(withou chemo)
embolization agent:KMG microsphere( 150-450µm,0.2-2g)
干预措施: Therapeutic Chemoembolization (Procedure)
结局指标
主要结局
Time to progression
时间窗: 3 years
Time to progression
次要结局
- total survival(3 year)
- remission rate(3 years)