Sorafenib Plus Transarterial Chemoembolization Versus Sorafenib Alone as Postoperative Adjuvant Treatment for Resectable Primary Advanced Hepatocellular Carcinoma: A Phase 3, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Recurrence-free survival
研究概览
简要总结
This trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to explore the efficacy and safety of Sorafenib combined with transarterial chemoembolization as adjuvant treatment for resectable advanced hepatocellular carcinoma, compared with Sorafenib alone. The primary endpoint is recurrence-free survival. This trial planned to recruit 158 patients who received curative hepatic resection with resectable advanced hepatocellular carcinoma. The patients will be randomized into Sorafenib group and Sorafenib+TACE group as 1:1 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Primary hepatocellular carcinoma without any treatments.
- •Received curative hepatic resection
- •ECOG score 0-1
- •Child-Pugh grade A
- •Sufficient liver and kidney function
排除标准
- •Diffused lesions; tumor thrombosis in SMV or IVC.
- •Extra-hepatic metastasis.
- •Contraindication of TACE, like portal-systemic shunt, obvious atherosclerosis, etc.
- •Allergic to the contrast agent of TACE
- •Dysfunction of liver, kidney or bone marrow.
- •Concomitant other malignant tumor or HIV infection
研究组 & 干预措施
Sorafenib
Patients in this arm will take Sorafenib orally with the dose of 400mg bid on the third day after randomization till recurrence or the end of this trial. If any drug related adverse event occurred, the dosage will be reduced.
干预措施: Sorafenib (Drug)
Sorafenib plus TACE
Patients in this arm will take Sorafenib orally with the dose of 400mg bid on the third day after randomization till recurrence or the end of this trial. TACE will be performed on the fourth day after randomization. If any drug related adverse event occurred, the dosage will be reduced.
干预措施: Sorafenib (Drug)
Sorafenib plus TACE
Patients in this arm will take Sorafenib orally with the dose of 400mg bid on the third day after randomization till recurrence or the end of this trial. TACE will be performed on the fourth day after randomization. If any drug related adverse event occurred, the dosage will be reduced.
干预措施: Transarterial chemoembolization (Procedure)
结局指标
主要结局
Recurrence-free survival
时间窗: 2 years
Recurrence-free survival indicates the interval between randomization and tumor recurrence or death.\[0-2 years\] Longer RFS time indicates better prognosis.
次要结局
- Quality of life(2 years)
- Overall survival(2 years)
- Severe adverse events(2 years)
- Time to recurrence(2 years)
研究者
Ming Kuang
Vice-president
First Affiliated Hospital, Sun Yat-Sen University