Randomized Control Trial of Transarterial Chemotherapy (TAC) Versus Oral Thalidomide and Capecitabine in the Treatment of Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Survival rate-
研究概览
简要总结
In India, majority of our patients have advanced hepatocellular carcinoma (HCC) at presentation and hence are unsuitable for the available curative treatment options. In such patients the treatment options are mainly palliative. Transarterial chemoembolization (TACE), transarterial chemotherapy (TAC) and various forms of oral chemotherapy are the only available options currently. Many patients have more advanced disease with the involvement of branches of portal vein. This further limits the therapeutic options. According to Barcelona Clinic Liver Cancer (BCLC) staging, involvement of portal vein precludes any standard form of therapy. TAC and oral chemotherapy has been tried in this group of patients by few researchers. Which treatment (TAC or oral chemotherapy) would be better suitable for advanced stage (BCLC C) needs to be explored. However, there are no randomized controlled trials (RCT's) available.
TAC is the procedure for treating patients of HCC with portal vein invasion where only the chemotherapeutic drugs are injected into the feeding vessels of the tumor with no subsequent embolization of the feeding vessels.
In order to select a modality which would produce better outcomes in advanced HCC patients (BCLC C), this study was planned.
详细描述
- Aim of the study: To see the efficacy of transarterial chemotherapy in prolonging the survival of patients with unresectable HCC when compared to oral chemotherapy 2. Diagnostic criteria
o Cirrhosis of liver- Diagnosis will be founded on the basis of clinical, biochemical, imaging and endoscopy findings.
o Hepatocellular carcinoma- when any one of the following is present
-
Two imaging modalities (dual phase CT (DPCT)/ contrast enhanced MRI) showing arterialization of the hepatic mass
-
Alpha feto protein (AFP) more than 400ng/ml along with arterialization on one imaging modality (DPCT/ contrast enhanced MRI)
-
Fine-needle aspiration cytology (FNAC)
-
Definitions
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
- •Blocked Main portal vein
- •No history of drug allergy
- •Informed written consent of patient.
排除标准
- •Child's C cirrhosis
- •Performance status 3-5
- •Extra hepatic disease
- •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
- •Pregnancy
研究组 & 干预措施
Transarterial chemotherapy
Doxorubicin 50mg, Cisplatin 100mg
干预措施: Transarterial chemotherapy (Procedure)
Oral chemotherapy
Thalidomide---50-300mg once a day Capecitabine---- 500-1500mg once a day
干预措施: Oral chemotherapy (Drug)
结局指标
主要结局
Survival rate-
时间窗: 1 year
Survival rate to be calculated from the start of Transarterial chemotherapy
次要结局
- Tumor response(1 year)
研究者
Subrat Kumar Acharya
Professor & Head
All India Institute of Medical Sciences, New Delhi