NCT05811481招募中不适用
Clinical Research and Laboratory Animal Ethics Committee of the First Affiliated Hospital of Sun Yat-sen University
WenBo Guo1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2022年12月27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
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
. 1 Clarify the difference in efficacy of regofinib combined with TACE compared with second-line treatment of advanced liver cancer; 2. To evaluate the safety and prognostic imaging factors of regorofenib in advanced second-line therapy; 3, to explore whether it is necessary to increase the treatment of TACE in the second-line treatment of advanced HCC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •( - ) After pathological / clinical diagnosis of hepatocellular carcinoma or radical resection of hepatocellular carcinoma; ( - ) CNLC Ⅲa Patients with intrahepatic recurrence before (including a); ( - ) Previous failure of first-line systemic treatment; ( - ) Age: 18-75 years old; ( - ) Child-Pugh 7 points; ( - ) ECOG PS Grade 0-2; ( - ) At least one measurable lesion in the liver.
排除标准
- •( - ) Known hepatobiliary tubular cell carcinoma and mixed cell carcinoma and fibrolamellar cell carcinoma; ( - ) Previous (within 5 years) or concurrent other incurable malignant tumors; ( - ) Having received local treatment, systemic chemotherapy, radiotherapy other than TACE during the first-line systemic treatment; ( - ) During the second-line systemic treatment, I also received local treatment, systemic chemotherapy, radiotherapy other than TACE; ( - ) Serious uncontrollable systemic and other systemic diseases, such as uremia, cardiovascular and cerebrovascular accidents; ( - ) Allergy to any drug included in the study; ( - ) Pregnant or lactating women;
研究组 & 干预措施
Two treatment groups
Regorafenib + TACE
干预措施: TACE (Procedure)
Two treatment groups
Regorafenib + TACE
干预措施: Regorafenib (Drug)
Treatment ate group
Regorafinib
干预措施: Regorafenib (Drug)
结局指标
主要结局
Overall survival
时间窗: 2022.12.27-2025.09.30
defined as the time between the start of second-line treatment and the end of follow-up / death.
次要结局
- Progression-free survival for the first subsequent treatment PFS 2(2022.12.27-2025.09.30)
研究者
WenBo Guo
professor
First Affiliated Hospital, Sun Yat-Sen University
研究点 (1)
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