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

Not Applicable

Not yet recruiting

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT06023147
• Lead Sponsor: Xuhua Duan

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.

Study Timeline

• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-08-29
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Study First Posted: 2023-09-05
• Last Update Posted: 2023-09-07
• Study Start: 2023-09-10
• Primary Completion: 2024-09-10
• Study Completion: 2025-09-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 298

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (27)

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

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