Thermal Ablation Combined With Low-dose Donafinib for Early Recurrent Hepatocellular Carcinoma: a Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Tumor-free survival rate
研究概览
简要总结
This study intends to evaluate the efficacy and safety of low-dose adjuvant donafenib after thermal ablation for early recurrent HCC within Milan criteria.
详细描述
Thermal ablation is available as the major curative treatments for early-stage recurrent HCC. Donafenib was inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. No study has evaluated low-dose donafenib as adjuvant therapy after thermal ablation. There needs further investigation to explore the efficacy and safety of the combination treatment. Thus, the investigators carried out this prospective, randomized, open-label, phase II trial study to find out it.
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
- •were aged 18-75 years;
- •had recurrent HCC (RHCC) diagnosed by imaging studies, the first or the second RHCC;
- •RHCC met the Milan criteria, namely single RHCC lesion less than 5 cm in diameter or no more than 3 tumors (each ≤3 cm in diameter);
- •the early RHCC (recurrent time <1 year)
- •patients were unwilling to undergo repeat hepatectomy or liver transplantation;
- •had well-preserved liver function, i.e., Child-Pugh class A or B, and prolonged prothrombin time≤5 s;
- •patients had an Eastern Cooperative Oncology Group performance status score ≤
- •Ability to understand the protocol and to agree to and sign a written informed consent document.
排除标准
- •were under 18 years or over 75 years of age;
- •primary HCC;
- •recurrent HCC beyond Milan criteria;
- •RHCC with metastasis or macrovascular tumor thrombus
研究组 & 干预措施
Thermal ablation
Patients only accepted thermal ablation (microwave ablation,radiofrequency ablation)
干预措施: Thermal ablation (Procedure)
Microwave ablation plus Donafenib
Patients accepted thermal ablation (microwave ablation,radiofrequency ablation) plus Donafenib (100mg, bid)
干预措施: Thermal ablation (Procedure)
Microwave ablation plus Donafenib
Patients accepted thermal ablation (microwave ablation,radiofrequency ablation) plus Donafenib (100mg, bid)
干预措施: Donafenib (Drug)
结局指标
主要结局
Tumor-free survival rate
时间窗: 24 months
Progression was defined as progressive disease after thermal ablation by independent radiologic review according to mRECIST or death from any cause
次要结局
- Overall survival (OS)(36 months)
- Adverse events(36 months)
研究者
Zhou Qunfang
MD
Sun Yat-sen University