NCT00555334Unknown4 期
Nucleoid as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2007年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall survivals
研究概览
简要总结
The purpose of the investigators' study is to prospectively evaluate whether nucleoid antiviral therapy will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (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
- Single (Participant)
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
- •Inclusion Criteria:
- •Age 18 - 75 years, who refused surgery;
- •A solitary HCC ≤ 7.0cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 3.0cm in diameter
- •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
- •The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed
- •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; or
- •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
- •History of organ allograft
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- •Known or suspected allergy to the investigational agent or any agent given in association with this trial
- •Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
- •Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
- •Excluded therapies and medications, previous and concomitant:
- •Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization.
- •Prior use of systemic investigational agents for HCC
- •Autologous bone marrow transplant or stem cell rescue within four months of start of study drug
研究组 & 干预措施
1
Experimental
nucleoid antiviral therapy after RFA
干预措施: RFA (Procedure)
1
Experimental
nucleoid antiviral therapy after RFA
干预措施: lamivudine or entecavir (Drug)
2
Active Comparator
RFA only
干预措施: RFA (Procedure)
结局指标
主要结局
Overall survivals
时间窗: 3, 5-years
次要结局
- Recurrence rates(3, 5-years)
研究者
研究点 (1)
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