Randomized Control Trial (RCT) of Transarterial Chemoembolization (TACE) Versus TACE and Oral Drug Therapy in the Treatment of Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 2
- 主要终点
- Survival rate- calculated from the start of TACE
研究概览
简要总结
Background Hepatocellular carcinoma, a malignant tumor of liver is one of the most common cancers worldwide. All India Institute Of Medical Sciences (AIIMS) being a tertiary care hospital receives about two to three cases of Hepatocellular carcinoma (HCC) each day in our Gastroenterology out patient department. Most of these patients present late when the disease is already advanced and no curative therapies can be offered. At this stage, palliative therapy forms the mainstay of treatment. This includes TACE or Oral chemotherapy. Whether oral chemotherapy administered along with TACE potentiates the effect and further prolongs survival, needs to be ascertained. No studies of this kind are available.
This prospective study is therefore designed to address this issue.
详细描述
- Subjects Consecutive patients of unresectable HCC diagnosed from January 2006 at the liver clinic, AIIMS will be included in the study if they fulfill the following criteria-
Inclusion criteria · Patients above 12 years of age with performance status (PST)score of 0-2
· Unresectable HCC with underlying Child's A/B cirrhosis
· Normal Main portal vein and its branches
- Normal Inferior vena cava
- No history of drug allergy
- Informed written consent of patient.
- Less than 50% involvement of liver by HCC
Exclusión criteria
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
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients above 12 years of age with performance status (PST)score of 0-2
- •Unresectable HCC with underlying Child's A/B cirrhosis
- •Normal Main portal vein and its branches
- •Normal Inferior vena cava
- •No history of drug allergy
- •Informed written consent of patient.
- •Less than 50% involvement of liver by HCC
排除标准
- •Unresectable HCC with underlying Child's C cirrhosis
- •Performance status 3-5
- •Extrahepatic disease
- •Vascular involvement
- •Co-morbid illness like coronary artery disease, congestive heart failure, chronic renal failure etc
- •Previous history of encephalopathy/ upper gastrointestinal bleed in the last six months
- •HCC in a female of child bearing age
结局指标
主要结局
Survival rate- calculated from the start of TACE
次要结局
- a) Tumor response on dual phase CECT b) Patient tolerance c) Childs' status of cirrhosis- will be ascertained at one and two years of follow up depending upon the Childs' scoreScore <6- Childs'A, 7-9 Childs'B and >10 Childs'C