radioFrequency Ablation With or Without RadioTherapy for Small HEpatocellulaR Carcinoma: a Randomized Control Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 主要终点
- the 2-years recurrence rate
研究概览
简要总结
Radiofrequency ablation (RFA) and hepatic resection are main treatments for early stage hepatocellular carcinoma. Many randomized controlled trials found these two treatments have similar short term overall survival. However, hepatic resection is associated with higher long-term overall survival. These results reveal that tumor recurrence rate after RFA is higher than that after hepatic resection. And minimal residual tumor may exist after RFA. Radiotherapy after RFA may be effective to prevent early tumor recurrence.
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 (Outcomes Assessor)
盲法说明
Outcomes (recurrence or death) Assessor is blind about the interventions.
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
- •Clinical diagnoses of hepatocellular carcinoma based on EASL.
- •Tumors, either single, >2 and < 5 cm in size or no more than 3 for size < 3 cm.
- •Patients must have a performance status of ECOG score <
- •Patients must have adequate liver reservation and adequate hemogram.
- •Pugh-Child's Score <
- •The serum total bilirubin level are < 2 mg/dl.
- •The prothrombin times are < 3 sec above normal control.
- •The platelet are > 75 x 109/L.
- •Patient must have serum creatinine < 1.5 mg/dl
- •Cardiac function with NYHA classification < Grade II
- •HBsAg (+) .
- •Signed informed consent.
排除标准
- •HCCs with radiological evidence of macrovascular invasion or extrehepatic metastasis are not eligible.
- •Patients with other systemic diseases which required concurrent usage of glucoticosteroid or immunosuppressant agent(s) are not eligible.
- •Patients with advanced second primary malignancy are not eligible.
- •Patients with pregnancy or breast-feeding are not eligible.
- •Patients with severe cardiopulmonary diseases are not eligible.
- •Patients with clinically significant psychiatric disorder are not eligible.
- •Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.
- •Patients who had prior antitumor therapy for HCC are not eligible.
- •Anti-HCV positive patients are not eligible.
研究组 & 干预措施
Radiofrequency ablation with radiotherapy
Patients in this arm will receive liver radiotherapy around the primary tumor margin within one month after radiofrequency ablation for hepatocellular carcinoma.
干预措施: Radiofrequency ablation with radiotherapy (Drug)
Radiofrequency ablation alone
Patients in this arm will only receive radiofrequency ablation for hepatocellular carcinoma.
干预措施: Radiofrequency ablation alone (Drug)
结局指标
主要结局
the 2-years recurrence rate
时间窗: 2 year
Two year recurrence rate between the two groups will be compared.
次要结局
- the 2-years recurrence-free survival(2 year)
- the 2-years overall survival.(2 year)
研究者
Jian-Hong Zhong
Professor
Guangxi Medical University