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A Real-world Study of the Short-term Efficacy and Safety of E-TACE in Patients With Hepatocellular Carcinoma (HCC)

Primary Purpose

Hepatocellular Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
E-TACE
Sponsored by
Xuhua Duan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring E-TACE

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 1.Patients judged by the investigators to be unsuitable for inclusion in this study.

Sites / Locations

  • Huai He Hospital of Henan University
  • Luo He Central Hospital
  • WuYang People's Hospital
  • Luo Yang Central Hospital
  • The First Affiliated Hospital of Henan University of science and Technology
  • The Second Affiliated Hospital of Henan University of Science and Technology
  • Deng zhou People's Hospital
  • First People's Hospital of Ping Dingshan
  • General Hospital of Pingmei Shenma Group
  • Lushan Xian People's Hospital
  • Second People's Hospital of Ping Dingshan
  • The 989 Hospital of the Chinese People's Liberation Army Joint Logistic Support Force
  • Puyang People's Hospital
  • San Menxia Central Hospital
  • Yellow River San Menxia Hospital
  • Central Hospital of Yongcheng
  • First People's Hospital of Shangqiu
  • Shangqiu Municipal Hospital
  • The People's Hospital of Yongcheng
  • Tumor Hospital of Xinyang
  • Henan Provincial People's Hospital
  • The Sixth Peoples Hospital of Zhengzhou
  • The Third Peoples Hospital of Zhengzhou
  • First People's Hospital of Zhoukou
  • Xihua Xian People's Hospital
  • Zhou Kou Central Hospital
  • Zhou Kou Hospital of TCM

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

E-TACE

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
Proportion of patients with reduction in stable in tumor burden of a predefined amount

Secondary Outcome Measures

6/12 months progression-free survival (PFS) rate
Rate of progression free survival in 6/12 months
6/12 months overall survival (OS) rate
Rate of over survival rate in 6/12 months
Disease control rate (DCR)
Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount

Full Information

First Posted
August 29, 2023
Last Updated
September 4, 2023
Sponsor
Xuhua Duan
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1. Study Identification

Unique Protocol Identification Number
NCT06023147
Brief Title
A Real-world Study of the Short-term Efficacy and Safety of E-TACE in Patients With Hepatocellular Carcinoma (HCC)
Official Title
A Real-world Study of the Short-term Efficacy and Safety of Elaboration Transcatheter Arterial Chemoembolization (E-TACE) in Patients With Hepatocellular Carcinoma (HCC)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 10, 2023 (Anticipated)
Primary Completion Date
September 10, 2024 (Anticipated)
Study Completion Date
September 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xuhua Duan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
E-TACE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
298 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E-TACE
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
E-TACE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Proportion of patients with reduction in stable in tumor burden of a predefined amount
Time Frame
1, 3, 6,12 months after the first E-TACE treatment, up to death or 12 months
Secondary Outcome Measure Information:
Title
6/12 months progression-free survival (PFS) rate
Description
Rate of progression free survival in 6/12 months
Time Frame
6/12 months
Title
6/12 months overall survival (OS) rate
Description
Rate of over survival rate in 6/12 months
Time Frame
6/12 months
Title
Disease control rate (DCR)
Description
Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount
Time Frame
1, 3, 6,12 months after the first E-TACE treatment, up to death or 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 1.Patients judged by the investigators to be unsuitable for inclusion in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuhua Duan
Phone
+8613523402912
Email
xuhuaduan@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xinwei Han
Phone
13803842129
Email
zzudxh@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuhua Duan
Organizational Affiliation
The First Affiliated Hospital of Zhengzhou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huai He Hospital of Henan University
City
Kaifeng
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang He
First Name & Middle Initial & Last Name & Degree
Xiang He
Facility Name
Luo He Central Hospital
City
Luohe
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaoxian Liu
First Name & Middle Initial & Last Name & Degree
Yaoxian Liu
Facility Name
WuYang People's Hospital
City
Luohe
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenguang Pang
First Name & Middle Initial & Last Name & Degree
Chenguang Pang
Facility Name
Luo Yang Central Hospital
City
Luoyang
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fazhong Li
Phone
18537919361
First Name & Middle Initial & Last Name & Degree
Fazhong Li
Facility Name
The First Affiliated Hospital of Henan University of science and Technology
City
Luoyang
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huanzhang Niu
Phone
18567635732
Email
niuhuanzhang@126.com
First Name & Middle Initial & Last Name & Degree
Huanzhang Niu
Facility Name
The Second Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liyu Song
First Name & Middle Initial & Last Name & Degree
Liyu Song
Facility Name
Deng zhou People's Hospital
City
Nanyang
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuguo Dan
First Name & Middle Initial & Last Name & Degree
Xuguo Dan
First Name & Middle Initial & Last Name & Degree
yanliang Li
Facility Name
First People's Hospital of Ping Dingshan
City
Pingdingshan
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hengfei Ma
First Name & Middle Initial & Last Name & Degree
Hengfei Ma
Facility Name
General Hospital of Pingmei Shenma Group
City
Pingdingshan
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peixin Zhu
First Name & Middle Initial & Last Name & Degree
Peixin Zhu
Facility Name
Lushan Xian People's Hospital
City
Pingdingshan
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanchun Li
First Name & Middle Initial & Last Name & Degree
Yanchun Li
Facility Name
Second People's Hospital of Ping Dingshan
City
Pingdingshan
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kunli Cao
First Name & Middle Initial & Last Name & Degree
Kunli Cao
Facility Name
The 989 Hospital of the Chinese People's Liberation Army Joint Logistic Support Force
City
Pingdingshan
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanliang Feng
First Name & Middle Initial & Last Name & Degree
Yanliang Feng
Facility Name
Puyang People's Hospital
City
Puyang
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangli Chen
First Name & Middle Initial & Last Name & Degree
Guangli Chen
Facility Name
San Menxia Central Hospital
City
Sanmenxia
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenping Li
First Name & Middle Initial & Last Name & Degree
Zhenping Li
Facility Name
Yellow River San Menxia Hospital
City
Sanmenxia
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hailong Gong
First Name & Middle Initial & Last Name & Degree
Hailong Gong
Facility Name
Central Hospital of Yongcheng
City
Shangqiu
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zuoyu Liang
First Name & Middle Initial & Last Name & Degree
Zuoyu Liang
Facility Name
First People's Hospital of Shangqiu
City
Shangqiu
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Zhou
First Name & Middle Initial & Last Name & Degree
Jian Zhou
Facility Name
Shangqiu Municipal Hospital
City
Shangqiu
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baoning Guo
First Name & Middle Initial & Last Name & Degree
Baoning Guo
Facility Name
The People's Hospital of Yongcheng
City
Shangqiu
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Zhao
First Name & Middle Initial & Last Name & Degree
Yi Zhao
Facility Name
Tumor Hospital of Xinyang
City
Xinyang
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Lei
First Name & Middle Initial & Last Name & Degree
Ting Lei
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangshao Cao
Phone
15093103069
Email
yajuncao98@126.com
First Name & Middle Initial & Last Name & Degree
Guangshao Cao
Facility Name
The Sixth Peoples Hospital of Zhengzhou
City
Zhengzhou
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dengke Zhang
First Name & Middle Initial & Last Name & Degree
Dengke Zhang
Facility Name
The Third Peoples Hospital of Zhengzhou
City
Zhengzhou
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Wei
First Name & Middle Initial & Last Name & Degree
Dong Wei
Facility Name
First People's Hospital of Zhoukou
City
Zhoukou
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haibo Wang
First Name & Middle Initial & Last Name & Degree
Haibo Wang
Facility Name
Xihua Xian People's Hospital
City
Zhoukou
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongjie Wang
First Name & Middle Initial & Last Name & Degree
Hongjie Wang
Facility Name
Zhou Kou Central Hospital
City
Zhoukou
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng Xing
Phone
18336547709
First Name & Middle Initial & Last Name & Degree
Zhou Kou Xing
Facility Name
Zhou Kou Hospital of TCM
City
Zhoukou
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changran Wang
First Name & Middle Initial & Last Name & Degree
Changran Wang

12. IPD Sharing Statement

Learn more about this trial

A Real-world Study of the Short-term Efficacy and Safety of E-TACE in Patients With Hepatocellular Carcinoma (HCC)

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