RCT Of Oral Thalidomide And Capecitabine Versus Supportive Therapy In The Treatment Of Unresectable Hepatocellular Carcinoma (BCLC D)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
Background Hepatocellular carcinoma, a malignant tumour 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 the investigators 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 transarterial chemoembolization (TACE) or Oral chemotherapy. Many patients also have involvement of branches of portal vein, which further limit therapeutic options. According to Barcelona Clinic Liver Cancer (BCLC) staging of liver cancer, involvement of portal vein precludes any standard form of therapy. These patients have been recommended for experimental therapies. Various forms of chemotherapy have been tried this group of patients. HCC is a vascular tumour and thalidomide is an anti-angiogenic drug and inhibits vascularity and has been used in the treatment of HCC. Capecitabine is a novel drug, which gives continuous delivery of 5-FU and has been used in patients with HCC and has been found to be safe.
详细描述
Aim The aim of the study is to compare the effect of Oral chemotherapeutic drugs (Thalidomide and Capecitabine) in comparison with supportive therapy in the treatment of advanced Hepatocellular carcinoma in a randomized controlled trial.
Setting The study would be conducted at the All India Institute of Medical Sciences, New Delhi, a tertiary care teaching hospital, in the departments of Gastroenterology and Radiodiagnosis.
Diagnostic criteria
- Cirrhosis of liver- Diagnosis will be founded on the basis of clinical, biochemical, imaging and endoscopy findings.
- 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
- AFP more than 400ng/ml along with arterialisation on one imaging modality (DPCT/ contrast enhanced MRI)
- Fine needle aspiration cytology (FNAC)
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 70 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
- •ECOG performance status (PST) score of 3 or above
- •Underlying Child's A and B cirrhosis
- •More than 50% involvement of liver by tumor
- •Thrombosed main portal vein
- •HV/IVC thrombosis
- •Extra hepatic disease
- •Metastatic disease
- •Informed written consent of patient
排除标准
- •History of drug allergy
- •Co-morbid illness like coronary artery disease, congestive heart failure, chronic renal failure etc
- •Pregnancy
- •Outstation patients from distant areas not in a position to follow up
研究组 & 干预措施
Supportive
Supportive therapy
干预措施: Supportive (Other)
Oral
Oral thalidomide and capecitabine
干预措施: Oral (Drug)
结局指标
主要结局
Survival
时间窗: 1 year
次要结局
- Tumour response(1 year)
- Number of patients with side effects(1 year)
- Quality of life(1 year)
- Change from baseline in Child status at 1 year(1 year)
研究者
Subrat Kumar Acharya
Professor and Head
All India Institute of Medical Sciences, New Delhi