Hepatocellular CarcinomaNCT06023147
A Real-world Study of the Short-term Efficacy and Safety of E-TACE in Patients With Hepatocellular Carcinoma (HCC)
A study testing E-TACE in people with Hepatocellular Carcinoma, run by Xuhua Duan at 27 sites in China.
Trial 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) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- E-TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 27 sitesChina
- Study dates
- 10 Sep 2023to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1.Patients judged by the investigators to be unsuitable for inclusion in this study.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
China27 sites
Huai He Hospital of Henan University
Kaifeng, Henan
Xiang He
Xiang He
Luo He Central Hospital
Luohe, Henan
Yaoxian Liu
Yaoxian Liu
WuYang People's Hospital
Luohe, Henan
Chenguang Pang
Chenguang Pang
Luo Yang Central Hospital
Luoyang, Henan
Fazhong Li, 18537919361
Fazhong Li
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan
Huanzhang Niu, 18567635732, niuhuanzhang@126.com
Huanzhang Niu
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Liyu Song
Liyu Song
Deng zhou People's Hospital
Nanyang, Henan
Xuguo Dan
Xuguo Dan
First People's Hospital of Ping Dingshan
Pingdingshan, Henan
Hengfei Ma
Hengfei Ma
General Hospital of Pingmei Shenma Group
Pingdingshan, Henan
Peixin Zhu
Peixin Zhu
Lushan Xian People's Hospital
Pingdingshan, Henan
Yanchun Li
Yanchun Li
Second People's Hospital of Ping Dingshan
Pingdingshan, Henan
Kunli Cao
Kunli Cao
The 989 Hospital of the Chinese People's Liberation Army Joint Logistic Support Force
Pingdingshan, Henan
Yanliang Feng
Yanliang Feng
Puyang People's Hospital
Puyang, Henan
Guangli Chen
Guangli Chen
San Menxia Central Hospital
Sanmenxia, Henan
Zhenping Li
Zhenping Li
Yellow River San Menxia Hospital
Sanmenxia, Henan
Hailong Gong
Hailong Gong
Central Hospital of Yongcheng
Shangqiu, Henan
Zuoyu Liang
Zuoyu Liang
First People's Hospital of Shangqiu
Shangqiu, Henan
Jian Zhou
Jian Zhou
Shangqiu Municipal Hospital
Shangqiu, Henan
Baoning Guo
Baoning Guo
The People's Hospital of Yongcheng
Shangqiu, Henan
Yi Zhao
Yi Zhao
Tumor Hospital of Xinyang
Xinyang, Henan
Ting Lei
Ting Lei
Henan Provincial People's Hospital
Zhengzhou, Henan
Guangshao Cao, 15093103069, yajuncao98@126.com
Guangshao Cao
The Sixth Peoples Hospital of Zhengzhou
Zhengzhou, Henan
Dengke Zhang
Dengke Zhang
The Third Peoples Hospital of Zhengzhou
Zhengzhou, Henan
Dong Wei
Dong Wei
First People's Hospital of Zhoukou
Zhoukou, Henan
Haibo Wang
Haibo Wang
Xihua Xian People's Hospital
Zhoukou, Henan
Hongjie Wang
Hongjie Wang
Zhou Kou Central Hospital
Zhoukou, Henan
Cheng Xing, 18336547709
Zhou Kou Xing
Zhou Kou Hospital of TCM
Zhoukou, Henan
Changran Wang
Changran Wang
About this study
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)
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)
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- E-TACE
- Keywords
- E-TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-TACEProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| E-TACE | Experimental | 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. Receives: Procedure: E-TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Proportion of patients with reduction in stable in tumor burden of a predefined amount
Measured: 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
Rate of progression free survival in 6/12 months
Measured: 6/12 months
6/12 months overall survival (OS) rate
Rate of over survival rate in 6/12 months
Measured: 6/12 months
Disease control rate (DCR)
Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount
Measured: 1, 3, 6,12 months after the first E-TACE treatment, up to death or 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start10 Sep 2023 (estimated)
- Primary completion10 Sep 2024 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuhua Duan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuhua Duan, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Xuhua Duan, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023147
- Sponsor's protocol ID
- 2023-KY-0737-002
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06023147
- Acronym / sponsor ID
- 2023-KY-0737-002
- Conditions
- Hepatocellular Carcinoma
- Keywords
- E-TACE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 298 participants (estimated)
- Lead sponsor
- Xuhua DuanUniversity, hospital or other
- Study start
- 10 Sep 2023 (estimated)
- Primary completion
- 10 Sep 2024 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-TACE | Experimental | Procedure: E-TACEProcedure: 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1.Patients judged by the investigators to be unsuitable for inclusion in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-TACEThe 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. | Procedure or surgery | E-TACE |
Primary outcome
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
3 secondary outcomes
6/12 months progression-free survival (PFS) rate
Time frame: 6/12 months
6/12 months overall survival (OS) rate
Time frame: 6/12 months
Disease control rate (DCR)
Time frame: 1, 3, 6,12 months after the first E-TACE treatment, up to death or 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuhua Duan principal investigator
The First Affiliated Hospital of Zhengzhou University
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-TACE in people with Hepatocellular Carcinoma, run by Xuhua Duan at 27 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuhua Duan (+8613523402912, xuhuaduan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 1, 3, 6,12 months after the first E-TACE treatment, up to death or 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.