TRansarterial ChEmoembolization Plus SorAfenib Versus Transarterial Chemoembolization Alone for Recurrent Intermediate Hepatocellular Carcinoma: A Phase 3, Open Label, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The study is a multicenter phase III randomized trial. The purpose is to investigate both the efficacy and safety of transarterial chemoembolization (TACE) plus sorafenib versus TACE alone for recurrent intermediate hepatocellular carcinoma patients.
详细描述
The trial will recruit 162 patients with recurrent intermediate HCC, and they will be randomized (1:1) into two groups (TACE+sorafenib group, TACE group). Patients in TACE+sorafenib group will receive TACE one day following oral sorafenib (initial dose: 400mg BID). Patients in the TACE group will receive TACE alone.
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;
- •Diagnosed as HCC based on the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis;
- •Initial tumor recurrence following curative surgical resection (R0 hepatectomy) (two to three lesions with at least one lesion >3 cm in diameter or more than three lesions of any diameter). Tumor burden ≤ 50% and no distant metastasis and macroscopic vascular invasion;
- •Histologically confirmed microvascular invasion in the specimen slices of surgically removed primary tumor;
- •Eastern Cooperative Oncology Group scoring 0-1;
- •Child-Pugh A class;
- •At least 3 months of life expectancy;
- •Adequate hematologic, hepatic and renal function: absolute neutrophil count ≥ 1.5x10^9/L, platelet ≥ 60 x10^9/L, Hb ≥ 90g/L, albumin ≥ 30g/L, total bilirubin ≤ 1.5 x upper limit of normal (ULN) , ALT < 5×ULN, AST < 5×ULN, alkaline phosphatase < 4×ULN, extended prothrombin time not exceeding 6s of ULN, creatine<1.5×ULN.
排除标准
- •Have lesions which are diffuse or can not be evaluated via imaging. Tumor burden>50%;
- •Have a history of hepatic encephalopathy, refractory ascites, severe esophageal and gastric varices or variceal bleeding and obstructive jaundice;
- •Have contraindications for TACE;
- •Have metastasis in central nervous system;
- •Allergic to intravenous contrast agents;
- •Pregnant or breastfeeding women, or expecting to conceive or father children within two years;
- •Infection of HIV, known syphilis requiring treatment;
- •Have a known history of prior invasive malignancies within 5 years before enrolment;
- •Patients with allotransplantation;
- •Severe dysfunction involving heart, kidney or other organs;
- •Severe active clinical infection which is over grade 2 based on NCI-CTC version 4;
- •Patients with mental disorders which may impact informed consent;
- •Unable to orally take drugs;
- •Participating other clinical drug trials 12 months before enrolment.
结局指标
主要结局
Overall Survival
时间窗: 2 years
Defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.
次要结局
- Disease Control Rate(2 years)
- Adverse Events(2 years)
- Time To Progression(2 years)
- Objective Response Rate(2 years)
- Progression Free Survival(2 years)
- Scoring of Quality of Life(2 years)
研究者
Ming Kuang
The vice president
Sun Yat-sen University