Low-Dose Thalidomide as Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- progress free survival
研究概览
简要总结
The purpose of the investigators' study is to prospectively evaluate whether low-dose thalidomide adjuvant therapy will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC).
详细描述
Our previous studies showed that radiofrequency ablation (RFA) was as effective as liver resection for small hepatocellular carcinoma (HCC), but the recurrence rates after RFA were relatively high. Adjuvant therapies maybe reduce the recurrence rate. Phase 1 and 2 studies showed that thalidomide was a safety and effective treatment for HCC, especially for small HCC with liver cirrhosis. So we proposed that low-dose thalidomide adjuvant therapy will improve the disease progress free survivals and overall survivals after RFA for HCC.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 75 years, who refused surgery or first recurrence after hepatectomy
- •A solitary HCC 3.1-7.0cm in diameter, or 2-3 lesions, sums of diameters ≤ 7.0cm
- •Lesions being visible on ultrasound (US) and with an acceptable/safe path between the lesion and the skin as shown on US
- •No extrahepatic metastasis
- •No imaging evidence of invasion into the major portal/hepatic vein branches
- •No history of encephalopathy, ascites refractory to diuretics or variceal bleeding
- •A platelet count of > 40,000/mm3
- •No previous treatment of HCC except liver resection
排除标准
- •Patient compliance is poor
- •Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted
- •History of cardiac disease:
- •congestive heart failure > New York Heart Association (NYHA) class 2
- •active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted)
- •cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, *calcium channel blocker or digoxin
- •uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs)
- •Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
- •Known history of human immunodeficiency virus (HIV) infection
- •Known Central Nervous System tumors including metastatic brain disease
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
- •Distantly extrahepatic metastasis
研究组 & 干预措施
1
low-dose thalidomide adjuvant therapy after RFA for HCC
干预措施: thalidomide (Drug)
结局指标
主要结局
progress free survival
时间窗: 1,3,5-year
morbility
时间窗: one month
次要结局
- overall survival(1,3,5-year)
- recurrence rate(1,3,5-year)