NCT06581315招募中不适用
Efficacy and Safety of Donafenib as Adjuvant Therapy for Postoperative Patients With High-Risk Recurrent Hepatocellular Carcinoma: A Multicenter, Randomized Controlled Study
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2024年8月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- One year recurrence-free survival (RFS) rate
研究概览
简要总结
This study aims to evaluate the efficacy and safety of donafenib as adjuvant therapy for postoperative patients with high-risk recurrent Hepatocellular Carcinoma. This is a multicenter, randomized controlled study.
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
- •Participants underwent radical resection of hepatocellular carcinoma 4 weeks before randomization
- •High Risk of recurrence as assessed by tumor characteristics
- •Without any anti-tumor therapy before surgery, except preoperative TACE therapy, traditional Chinese medicine therapy and interferon therapy
- •Child-Pugh Class A statu
- •ECOG Performance Status of 0 or 1
- •CT/MR confirmed no recurrence or metastasis at ≥4 weeks after surgery
- •Expected survival time of no less than 3 months
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- •Evidence of residual or a history of spontaneous tumor rupture
- •Recurrent HCC
- •Prior received Liver transplantation
- •Prior anti tumor therapy for treatment of HCC (including sorafenib or any other molecular therapy, anti-PD-1 antibody and other immunotherapies, FOLFOX systemic chemotherapy) is excluded
- •AFP does not return to normal 4 weeks after operation
研究组 & 干预措施
Arm A (Donafenib)
Experimental
Participants will receive Donafenib treatment until disease recurrence or unacceptable toxicity or up to 1 years.
干预措施: Donafenib (Drug)
结局指标
主要结局
One year recurrence-free survival (RFS) rate
时间窗: 1 year
The proportion from randomization to 1 year without recurrence.
次要结局
- Recurrence-Free Survival (RFS )(6 years)
- Recurrence-Free Survival rate (RFS rate)(5 years)
- Overall Survival (OS)(6 years)
研究者
研究点 (1)
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