A Real-world Study of the Short-term Efficacy and Safety of E-TACE in Patients With Hepatocellular Carcinoma (HCC)
1 other identifier
interventional
298
1 country
27
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hepatocellular-carcinoma
Started Sep 2023
Shorter than P25 for not_applicable hepatocellular-carcinoma
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2023
CompletedFirst Posted
Study publicly available on registry
September 5, 2023
CompletedStudy Start
First participant enrolled
September 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2025
CompletedSeptember 7, 2023
September 1, 2023
1 year
August 29, 2023
September 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate (ORR)
Proportion of patients with reduction in stable in tumor burden of a predefined amount
1, 3, 6,12 months after the first E-TACE treatment, up to death or 12 months
Secondary Outcomes (3)
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
Study Arms (1)
E-TACE
EXPERIMENTALProcedure: 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.
Interventions
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
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xuhua Duanlead
Study Sites (27)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xuhua Duan
The First Affiliated Hospital of Zhengzhou University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 29, 2023
First Posted
September 5, 2023
Study Start
September 10, 2023
Primary Completion
September 10, 2024
Study Completion
September 10, 2025
Last Updated
September 7, 2023
Record last verified: 2023-09