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

Hepatocellular Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06023147
• Other study ID #: 2023-KY-0737-002
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 10, 2023
• Est. completion date: September 10, 2025

Study information

• Verified date: September 2023
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Xuhua Duan
• Phone: +8613523402912
• Email: xuhuaduan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 298
• Est. completion date: September 10, 2025
• Est. primary completion date: September 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Xuhua Duan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6/12 months progression-free survival (PFS) rate	Rate of progression free survival in 6/12 months	6/12 months
Secondary	6/12 months overall survival (OS) rate	Rate of over survival rate in 6/12 months	6/12 months
Secondary	Disease control rate (DCR)	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