Role of Drug Eluting Bead Transarterial Chemoebolization Versus Conventional Transarterial Chemoembolization in Treatment of Hepatocellular Carcinoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tumor size
研究概览
简要总结
Hepatocellular carcinoma (HCC) is listed as the sixth most common cancer worldwide and the third most frequent cause of cancer-related mortality. The majority of HCC cases occurs stem from chronic liver disease and cirrhosis.
Hepatocellular carcinoma accounts for approximately 70% to 90% of all primary liver cancers. Trans-arterial Chemoembolization is the most widely utilized and is considered the first-line treatment recommended for patients staged as intermediate HCC (Barcelona Clinic Liver Cancer stage B). If applied correctly, TACE can produce survival benefits without adversely affecting hepatic functional reserve.
Two TACE techniques have been used since 2004, conventional TACE (c-TACE) and TACE with drug-eluting beads (DEB-TACE). Conventional TACE was evidenced first to treat intermediate stage HCC patients.
详细描述
Hepatocellular carcinoma (HCC) is listed as the sixth most common cancer worldwide and the third most frequent cause of cancer-related mortality. The majority of HCC cases occurs stem from chronic liver disease and cirrhosis.
Hepatocellular carcinoma accounts for approximately 70% to 90% of all primary liver cancers. HCC patients have been suffering from poor prognosis with 5-year survival being roughly 10% to 15% for decades despite the progress in screening, diagnosis, and treatment, which is mainly resulted from that most patients are already in the moderate or advanced stage at diagnosis, whom can only receive palliative treatments.
At the level of the individual patient, concomitant cirrhosis and the number, size, and location of hepatocellular tumors will affect the treatment approach. In addition, multiple disease-related factors need to be taken into account, such as the presence of vascular involvement or extra-hepatic disease, when deciding on the best treatment options for these patients. Consequently, a multidisciplinary approach involving several physicians with different specialties (e.g., diagnostic and interventional radiologists, surgical oncologists, hepatologists, and medical oncologists) is necessary to determine the best approach to treatment and maximize potential outcomes for patients with HCC.
The liver has a dual vascular supply via the hepatic artery and the portal vein. The rationale of the trans-arterial embolotherapies is explained by the fact that liver malignancies are predominantly supplied by the hepatic artery, which allows delivering the chemotherapy directly to the tumor-feeding artery while sparing the healthy hepatic tissue mainly supplied by the portal vein.
Loco regional treatments are a set of therapeutic approaches that directly target tumors in the liver. Among the loco regional modalities, trans-arterial chemoembolization (TACE) involves the local delivery of chemotherapy to the tumor and is generally recommended for patients with liver-limited disease. Several randomized trials have been conducted to examine the efficacy and safety of TACE.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Child-Pugh A or B cirrhosis.
- •ECOG performance status (PS) Grade 2 or below.
- •BCLC stage B or C.
- •No serious concurrent medical illness.
- •Radiologically or histologically proven HCC (an alpha-fetoprotein level > 500 ug/ml in the presence of radiological findings suggestive of HCC in a patient with chronic HBV or HCV infection is considered eligible).
- •Unresectable and locally advanced disease without extra-hepatic disease.
- •Nodular tumor morphology with measurable lesion on CT with less than 50% involvement of liver by HCC.
- •Size of largest tumor is less than or equal to 15cm in largest dimension.
- •Number of main tumor is less than or equal to 5, excluding associated small satellite lesions.
- •Patent main portal vein.
排除标准
- •- Child-Pugh C cirrhosis (evidence of poor liver function).
- •History of significant concurrent medical illness such as ischemic heart disease or heart failure.
- •Serum creatinine level > 2 mg/dL.
- •Presence of extrahepatic metastasis.
- •Predominantly infiltrative lesion.
- •Diffuse tumor morphology with extensive lesions involving both lobes.
- •Hepatic artery thrombosis.
- •Thrombosis of the main portal vein.
- •Tumor invasion of portal branch of contralateral lobe.
研究组 & 干预措施
Drug Eluting Bead Transarterial Chemoembolization
Drug Eluting Bead Transarterial Chemoembolization
干预措施: Doxorubicin-Eluting Beads (Drug)
conventional Transarterial Chemoembolization
conventional Transarterial Chemoembolization
干预措施: Doxorubicin-Eluting Beads (Drug)
结局指标
主要结局
Tumor size
时间窗: four-six weeks after treatment
Triphasic CT scan of the liver measures the maximum diameter of tumor according to modified RECIST (mRecist) criteria.
次要结局
- Serum Alpha-fetoprotein level ng/ml.(four-six weeks after treatment)
研究者
Ahmed Elsaman Mohamed
Assistant Lecturer at department of diagnostic and interventional radiology
Sohag University
