A Real-world Study of the Short-term Efficacy and Safety of E-TACE in Patients With Hepatocellular Carcinoma (HCC)
NCT ID: NCT06023147
Last Updated: 2023-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
298 participants
INTERVENTIONAL
2023-09-10
2025-09-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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E-TACE
Procedure: The 100μm drug-loaded microspheres were loaded with 40mg-80mg anthracyclines at one milliliter/two milliliter (1mL/2mL), and then combined with non-isoionic contrast agents to embolize the tumor supplying arteries, and then 250μm or 400μm drug-loaded microspheres were loaded with 1mL/2mL chemotherapy drugs to embolize the tumor supplying arteries at different grades and diameters.
E-TACE
The 100μm drug-loaded microspheres were loaded with 40mg-80mg anthracyclines at 1mL/2mL, and then combined with non-isoionic contrast agents to embolize the tumor supplying arteries, and then 250μm or 400μm drug-loaded microspheres were loaded with 1mL/2mL chemotherapy drugs to embolize the tumor supplying arteries at different grades and diameters.
Interventions
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E-TACE
The 100μm drug-loaded microspheres were loaded with 40mg-80mg anthracyclines at 1mL/2mL, and then combined with non-isoionic contrast agents to embolize the tumor supplying arteries, and then 250μm or 400μm drug-loaded microspheres were loaded with 1mL/2mL chemotherapy drugs to embolize the tumor supplying arteries at different grades and diameters.
Eligibility Criteria
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Inclusion Criteria
2. 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;
3. 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;
4. Patients sign informed consent and have good compliance.
Exclusion Criteria
ALL
No
Sponsors
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Xuhua Duan
OTHER
Responsible Party
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Xuhua Duan
Associate Professor
Principal Investigators
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Xuhua Duan
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Locations
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Huai He Hospital of Henan University
Kaifeng, Henan, China
Luo He Central Hospital
Luohe, Henan, China
WuYang People's Hospital
Luohe, Henan, China
Luo Yang Central Hospital
Luoyang, Henan, China
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, China
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Deng zhou People's Hospital
Nanyang, Henan, China
First People's Hospital of Ping Dingshan
Pingdingshan, Henan, China
General Hospital of Pingmei Shenma Group
Pingdingshan, Henan, China
Lushan Xian People's Hospital
Pingdingshan, Henan, China
Second People's Hospital of Ping Dingshan
Pingdingshan, Henan, China
The 989 Hospital of the Chinese People's Liberation Army Joint Logistic Support Force
Pingdingshan, Henan, China
Puyang People's Hospital
Puyang, Henan, China
San Menxia Central Hospital
Sanmenxia, Henan, China
Yellow River San Menxia Hospital
Sanmenxia, Henan, China
Central Hospital of Yongcheng
Shangqiu, Henan, China
First People's Hospital of Shangqiu
Shangqiu, Henan, China
Shangqiu Municipal Hospital
Shangqiu, Henan, China
The People's Hospital of Yongcheng
Shangqiu, Henan, China
Tumor Hospital of Xinyang
Xinyang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The Sixth Peoples Hospital of Zhengzhou
Zhengzhou, Henan, China
The Third Peoples Hospital of Zhengzhou
Zhengzhou, Henan, China
First People's Hospital of Zhoukou
Zhoukou, Henan, China
Xihua Xian People's Hospital
Zhoukou, Henan, China
Zhou Kou Central Hospital
Zhoukou, Henan, China
Zhou Kou Hospital of TCM
Zhoukou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Xiang He
Role: primary
Yaoxian Liu
Role: primary
Chenguang Pang
Role: primary
Fazhong Li
Role: primary
Liyu Song
Role: primary
Xuguo Dan
Role: primary
Hengfei Ma
Role: primary
Peixin Zhu
Role: primary
Yanchun Li
Role: primary
Kunli Cao
Role: primary
Yanliang Feng
Role: primary
Guangli Chen
Role: primary
Zhenping Li
Role: primary
Hailong Gong
Role: primary
Zuoyu Liang
Role: primary
Jian Zhou
Role: primary
Baoning Guo
Role: primary
Yi Zhao
Role: primary
Ting Lei
Role: primary
Dengke Zhang
Role: primary
Dong Wei
Role: primary
Haibo Wang
Role: primary
Hongjie Wang
Role: primary
Cheng Xing
Role: primary
Changran Wang
Role: primary
Other Identifiers
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2023-KY-0737-002
Identifier Type: -
Identifier Source: org_study_id
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