A Real-world Study of the Short-term Efficacy and Safety of Elaboration Transcatheter Arterial Chemoembolization (E-TACE) in Patients With Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 298
- 试验地点
- 27
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a real world study to determine the short-term efficacy and safety of Elaboration transcatheter arterial chemoembolization (E-TACE) for hepatocellular carcinoma (HCC)
详细描述
Primary liver cancer is the fourth common malignant tumor and the second cause of death in China, which seriously threatens the life and health of Chinese people. Hepatocellular carcinoma accounts for 75% to 85% of primary liver cancer and is considered the leading cause of death in patients with cirrhosis, and its incidence is expected to continue to increase.
At present, the main treatment methods of liver cancer are surgical resection, liver transplantation, interventional therapy, etc., HCC patients are often advanced in initial diagnosis, coupled with cirrhosis, liver function intolerance and other factors, only about 15% of patients can receive surgical resection. Transcatheter arterial chemoembolization (TACE) has been applied in hepatocellular carcinoma for more than 40 years. TACE treatment can be divided into conventional TACE and Drug-eluting beads-transarterial chemoembolization (DEB-TACE) according to different embolic agents. DEB-TACE refers to the embolization therapy based on drug-eluting microspheres loaded with chemotherapy drugs, which can embolize the blood supplying artery of liver cancer to cause tumor ischemia and necrosis. At the same time, as a carrier of chemotherapy drugs, DEB-TACE has the advantage of continuously and steadily releasing drugs, so that the local tumor can reach a higher required concentration. Elaboration transcatheter arterial chemoembolization (E-TACE) is the elaboration transcatheter arterial branch selection of the tumor and the refined embolization is carried out by using uniform drug-loaded microsphere.
Although there have been a large number of randomized controlled studies on TACE treatment of HCC, due to the clear inclusion or exclusion criteria of randomized controlled studies. The results of the studies are different from the real diagnosis and treatment environment due to the limitations of treatment programs. This difference is called the efficacy effectiveness gap (EEG). In addition, the 2022 edition of China Liver Cancer Standard Diagnosis and Treatment Quality Control Indicators and 2022 edition of Primary Liver Cancer Diagnosis and Treatment Guidelines point out that TACE treatment for liver cancer needs to be standardized and refined, to reduce the heterogeneity of tumors leading to differences in TACE efficacy, and ultimately improve the survival rate and survival habits of liver cancer patients. There are currently no real-world studies on the efficacy and safety of E-TACE in the treatment of hepatocellular carcinoma. Therefore, this study intends to conduct a real-world study to evaluate the short-term efficacy and safety of E-TACE in the treatment of hepatocellular carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender and age are not limited;
- •HCC patients who strictly meet the clinical diagnostic criteria of the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 edition) or who have been confirmed by histopathology or cytology;
- •Patients who have at least one tumor supply artery available for superselection, and who are assessed by investigators or multi-disciplinary treatment (MDT) to require E-TACE therapy;
- •Patients sign informed consent and have good compliance.
排除标准
- •1.Patients judged by the investigators to be unsuitable for inclusion in this study.
结局指标
主要结局
Objective response rate (ORR)
时间窗: 1, 3, 6,12 months after the first E-TACE treatment, up to death or 12 months
Proportion of patients with reduction in stable in tumor burden of a predefined amount
次要结局
- 6/12 months progression-free survival (PFS) rate(6/12 months)
- 6/12 months overall survival (OS) rate(6/12 months)
- Disease control rate (DCR)(1, 3, 6,12 months after the first E-TACE treatment, up to death or 12 months)
研究者
Xuhua Duan
Associate Professor
The First Affiliated Hospital of Zhengzhou University
