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

Sponsor

Xuhua Duan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06023147

Collaborator

(none)

298

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Procedure: E-TACE	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

298 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Sep 10, 2023

Anticipated Primary Completion Date :

Sep 10, 2024

Anticipated Study Completion Date :

Sep 10, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Objective response rate (ORR) [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

Secondary Outcome Measures

6/12 months progression-free survival (PFS) rate [6/12 months]
Rate of progression free survival in 6/12 months
6/12 months overall survival (OS) rate [6/12 months]
Rate of over survival rate in 6/12 months
Disease control rate (DCR) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Huai He Hospital of Henan University	Kaifeng	Henan	China
2	Luo He Central Hospital	Luohe	Henan	China
3	WuYang People's Hospital	Luohe	Henan	China
4	Luo Yang Central Hospital	Luoyang	Henan	China
5	The First Affiliated Hospital of Henan University of science and Technology	Luoyang	Henan	China
6	The Second Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan	China
7	Deng zhou People's Hospital	Nanyang	Henan	China
8	First People's Hospital of Ping Dingshan	Pingdingshan	Henan	China
9	General Hospital of Pingmei Shenma Group	Pingdingshan	Henan	China
10	Lushan Xian People's Hospital	Pingdingshan	Henan	China
11	Second People's Hospital of Ping Dingshan	Pingdingshan	Henan	China
12	The 989 Hospital of the Chinese People's Liberation Army Joint Logistic Support Force	Pingdingshan	Henan	China
13	Puyang People's Hospital	Puyang	Henan	China
14	San Menxia Central Hospital	Sanmenxia	Henan	China
15	Yellow River San Menxia Hospital	Sanmenxia	Henan	China
16	Central Hospital of Yongcheng	Shangqiu	Henan	China
17	First People's Hospital of Shangqiu	Shangqiu	Henan	China
18	Shangqiu Municipal Hospital	Shangqiu	Henan	China
19	The People's Hospital of Yongcheng	Shangqiu	Henan	China
20	Tumor Hospital of Xinyang	Xinyang	Henan	China
21	Henan Provincial People's Hospital	Zhengzhou	Henan	China
22	The Sixth Peoples Hospital of Zhengzhou	Zhengzhou	Henan	China
23	The Third Peoples Hospital of Zhengzhou	Zhengzhou	Henan	China
24	First People's Hospital of Zhoukou	Zhoukou	Henan	China
25	Xihua Xian People's Hospital	Zhoukou	Henan	China
26	Zhou Kou Central Hospital	Zhoukou	Henan	China
27	Zhou Kou Hospital of TCM	Zhoukou	Henan	China

Sponsors and Collaborators

Xuhua Duan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xuhua Duan, Associate Professor, The First Affiliated Hospital of Zhengzhou University

ClinicalTrials.gov Identifier:

NCT06023147

Other Study ID Numbers:

2023-KY-0737-002

First Posted:

Sep 5, 2023

Last Update Posted:

Sep 7, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xuhua Duan, Associate Professor, The First Affiliated Hospital of Zhengzhou University

E-TACE

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Sep 7, 2023