A Randomized Controlled Trial of Ethanol-gelfoam Mixture(EGM) Versus Gelfoam for the Treatment of Arterioportal Shunts (APS) in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolization (TACE)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- APS improvement
研究概览
简要总结
Transcatheter arterial chemoembolization (TACE) is a key palliative treatment for patients with inoperable hepatocellular carcinoma (HCC). Arterioportal shunts (APS) can aggravate portal hypertension and the shunts let lipiodol flow to normal liver tissue and result in poor Lipiodol deposition in the tumor, causing liver ischemia.
Occlusion of APS is a vital and initial step for the following embolization of tumor. Ethanol-gelfoam mixture(EGM) and gelfoam only both can occlude APS in patients with hepatocellular carcinoma (HCC).
The aim of this study was to evaluate the efficacy and safety of EGM in treatment of APS in the procedure of TACE, and to analyze the prognostic factors for survival in this kind of patients.
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
- •Age > 18
- •Child-Pugh A or B cirrhosis
- •ECOG performance status Grade 2 or below
- •No serious concurrent medical illness
- •No prior treatment (including surgery) for HCC
- •Histologically or cytologically proven HCC (an alphafetoprotein level > 500 ug/ml in the presence of radiological findings suggestive of HCC in a patient with chronic HBV or HCV infection can be considered eligible at investigator's discretion)
- •Unresectable and locally advanced disease without extra-hepatic disease
- •Massive expansive or nodular tumor morphology with measurable lesion on CT
- •Size of largest tumor <= 15cm in largest dimension
- •Number of main tumor <= 5, excluding associated small satellite lesions
- •Arterioportal shunts (APS) is found in the angiography of HCC blood supply
排除标准
- •History of prior malignancy except skin cancer
- •History of significant concurrent medical illness such as ischemic heart disease or heart failure
- •History of acute tumor rupture
- •Serum creatinine level > 180 umol/L
- •Presence of biliary obstruction not amenable to percutaneous drainage
- •Child-Pugh C cirrhosis
- •History of hepatic encephalopathy, or
- •Intractable ascites not controllable by medical therapy, or
- •History of variceal bleeding within last 3 months, or
- •Serum total bilirubin level > 50 umol/L, or
- •Serum albumin level < 28g/L, or
- •INR > 1.3
- •Presence of extrahepatic metastasis
- •Predominantly infiltrative lesion
- •Diffuse tumor morphology with extensive lesions involving both lobes.
- •Hepatic artery thrombosis, or
- •Partial or complete thrombosis of the main portal vein, or
- •Tumor invasion of portal branch of contralateral lobe, or
- •Hepatic vein tumor thrombus
研究组 & 干预措施
TACE+EGM
Occlude APS with EGM and perform TACE sequentially
干预措施: TACE (Procedure)
TACE+EGM
Occlude APS with EGM and perform TACE sequentially
干预措施: EGM (Drug)
TACE+PVA
Occlude APS with PVA and perform TACE sequentially
干预措施: TACE (Procedure)
TACE+PVA
Occlude APS with PVA and perform TACE sequentially
干预措施: PVA (Drug)
结局指标
主要结局
APS improvement
时间窗: 2 month
Changes of Arterioportal Shunts Treated with PVA or EGM
overall survival
时间窗: 3 years
Defined as time (in days) from time of TACE non-eligibility to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period, respectively. Patients lost to follow-up or alive at the end of the study will be censored at the last date known to be alive.
次要结局
- progression free survival(every 8 weeks, upto 3 years from date of randomization)
- Time To Progression(every 8 weeks, upto 3 years from date of randomization)
- Response Rate(every 8 weeks, upto 3 years from date of randomization)
研究者
Hai-Bin Shi
Director of Radiology Department, the First Affiliated Hospital of Nanjing Medical University
Nanjing Medical University