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

September 4, 2023 updated by: Xuhua Duan

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

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

298

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Henan
      • Kaifeng, Henan, China
        • Huai He Hospital of Henan University
        • Contact:
          • Xiang He
        • Principal Investigator:
          • Xiang He
      • Luohe, Henan, China
        • Luo He Central Hospital
        • Contact:
          • Yaoxian Liu
        • Principal Investigator:
          • Yaoxian Liu
      • Luohe, Henan, China
        • WuYang People's Hospital
        • Contact:
          • Chenguang Pang
        • Principal Investigator:
          • Chenguang Pang
      • Luoyang, Henan, China
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Huanzhang Niu
      • Luoyang, Henan, China
        • Luo Yang Central Hospital
        • Contact:
          • Fazhong Li
          • Phone Number: 18537919361
        • Principal Investigator:
          • Fazhong Li
      • Luoyang, Henan, China
        • The Second Affiliated Hospital of Henan University of Science and Technology
        • Contact:
          • Liyu Song
        • Principal Investigator:
          • Liyu Song
      • Nanyang, Henan, China
        • Deng zhou People's Hospital
        • Contact:
          • Xuguo Dan
        • Principal Investigator:
          • Xuguo Dan
        • Sub-Investigator:
          • yanliang Li
      • Pingdingshan, Henan, China
        • First People's Hospital of Ping Dingshan
        • Contact:
          • Hengfei Ma
        • Principal Investigator:
          • Hengfei Ma
      • Pingdingshan, Henan, China
        • General Hospital of Pingmei Shenma Group
        • Contact:
          • Peixin Zhu
        • Principal Investigator:
          • Peixin Zhu
      • Pingdingshan, Henan, China
        • Lushan Xian People's Hospital
        • Contact:
          • Yanchun Li
        • Principal Investigator:
          • Yanchun Li
      • Pingdingshan, Henan, China
        • Second People's Hospital of Ping Dingshan
        • Contact:
          • Kunli Cao
        • Principal Investigator:
          • Kunli Cao
      • Pingdingshan, Henan, China
        • The 989 Hospital of the Chinese People's Liberation Army Joint Logistic Support Force
        • Contact:
          • Yanliang Feng
        • Principal Investigator:
          • Yanliang Feng
      • Puyang, Henan, China
        • Puyang People's Hospital
        • Contact:
          • Guangli Chen
        • Principal Investigator:
          • Guangli Chen
      • Sanmenxia, Henan, China
        • San Menxia Central Hospital
        • Contact:
          • Zhenping Li
        • Principal Investigator:
          • Zhenping Li
      • Sanmenxia, Henan, China
        • Yellow River San Menxia Hospital
        • Contact:
          • Hailong Gong
        • Principal Investigator:
          • Hailong Gong
      • Shangqiu, Henan, China
        • Central Hospital of Yongcheng
        • Contact:
          • Zuoyu Liang
        • Principal Investigator:
          • Zuoyu Liang
      • Shangqiu, Henan, China
        • First People's Hospital of Shangqiu
        • Principal Investigator:
          • Jian Zhou
        • Contact:
          • Jian Zhou
      • Shangqiu, Henan, China
        • Shangqiu Municipal Hospital
        • Contact:
          • Baoning Guo
        • Principal Investigator:
          • Baoning Guo
      • Shangqiu, Henan, China
        • The People's Hospital of Yongcheng
        • Contact:
          • Yi Zhao
        • Principal Investigator:
          • Yi Zhao
      • Xinyang, Henan, China
        • Tumor Hospital of Xinyang
        • Principal Investigator:
          • Ting Lei
        • Contact:
          • Ting Lei
      • Zhengzhou, Henan, China
        • Henan Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Guangshao Cao
      • Zhengzhou, Henan, China
        • The Sixth Peoples Hospital Of Zhengzhou
        • Contact:
          • Dengke Zhang
        • Principal Investigator:
          • Dengke Zhang
      • Zhengzhou, Henan, China
        • The Third Peoples Hospital of Zhengzhou
        • Contact:
          • Dong Wei
        • Principal Investigator:
          • Dong Wei
      • Zhoukou, Henan, China
        • First People's Hospital of Zhoukou
        • Principal Investigator:
          • Haibo Wang
        • Contact:
          • Haibo Wang
      • Zhoukou, Henan, China
        • Xihua Xian People's Hospital
        • Contact:
          • Hongjie Wang
        • Principal Investigator:
          • Hongjie Wang
      • Zhoukou, Henan, China
        • Zhou Kou Central Hospital
        • Contact:
          • Cheng Xing
          • Phone Number: 18336547709
        • Principal Investigator:
          • Zhou Kou Xing
      • Zhoukou, Henan, China
        • Zhou Kou Hospital of TCM
        • Contact:
          • Changran Wang
        • Principal Investigator:
          • Changran Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Gender and age are not limited;
  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:

1.Patients judged by the investigators to be unsuitable for inclusion in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 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
1, 3, 6,12 months after the first E-TACE treatment, up to death or 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
Time Frame: 1, 3, 6,12 months after the first E-TACE treatment, up to death or 12 months
Proportion of patients with reduction or keeping 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
6/12 months progression-free survival (PFS) rate
Time Frame: 6/12 months
Rate of progression free survival in 6/12 months
6/12 months
6/12 months overall survival (OS) rate
Time Frame: 6/12 months
Rate of over survival rate in 6/12 months
6/12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuhua Duan

Investigators

  • Principal Investigator: Xuhua Duan, The First Affiliated Hospital of Zhengzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 10, 2023

Primary Completion (Estimated)

September 10, 2024

Study Completion (Estimated)

September 10, 2025

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 5, 2023

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-KY-0737-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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