NCT01393197Unknown不适用
Clinical Trial of Transcatheter Arterial Chemoembolization (TACE)With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 2,480 人开始时间: 2011年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 2,480
- 试验地点
- 1
- 主要终点
- Time to progression
研究概览
简要总结
The purpose of this study is to evaluate the effects of Transcatheter Arterial Chemoembolization (TACE) with KMG microsphere in treating HCC. And to determine which one is better,KMG microsphere or lipiodol?
详细描述
The most important part of effect in TACE is embolization .But there is no clinical trials on which one is better,KMG microsphere or lipiodol? what effect did chemo play in the TACE treating HCC? Which one is better,routine dose or low dose? Experts in USA and Japan had their own researches and standpoints.We think it is important to push a clinical trail to answer these problem.
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
- 否
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
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 years)
- remission rate(3 years)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Transcatheter Arterial Chemoembolization With KMG Microsphere Treating Advance-stage Hepatocellular CarinomasCarcinoma, HepatocellularNCT01393093Tianjin Medical University Cancer Institute and Hospital2,840
撤回
2 期
TACE Plus PD-1 Antibody vs TACE Alone for Unresectable HCCHepatocellular CarcinomaNCT03782831Sun Yat-sen University
Unknown
4 期
TACE as an Adjuvant Therapy After Radiofrequency Ablation (RFA) for Hepatocellular CarcinomaLiver CancerHepatocellular CarcinomaNCT00556803Sun Yat-sen University120
招募中
2 期
TACE Combined With Sintilimab Plus Bevacizumab Biosimilar in Hepatocellular Carcinoma (BCLC-C Stage ): a Prospective Single-arm Phase II Clinical StudyHepatocellular CarcinomaNCT04796025Sun Yat-sen University34
Unknown
4 期
TACE Combined With Methylcantharidimide Tablets in the Treatment of Large and Unresectable Hepatocellular CarcinomaHepatocellular CarcinomaNCT03996681Suzhou Municipal Hospital22