Clinical trial NCT06023147: A Real-world Study of the Short-term Efficacy and Safety of E-TACE in Patients With Hepatocellular Carcinoma (HCC)
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: E-TACE
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 298
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 1, 3, 6,12 months after the first E-TACE treatment, up to death or 12 months
Secondary outcomes:
measure: 6/12 months progression-free survival (PFS) rate
timeFrame: 6/12 months
measure: 6/12 months overall survival (OS) rate
timeFrame: 6/12 months
measure: Disease control rate (DCR)
timeFrame: 1, 3, 6,12 months after the first E-TACE treatment, up to death or 12 months
Other outcomes:
Locations:
city: Kaifeng
country: China
facility: Huai He Hospital of Henan University
state: Henan
city: Luohe
country: China
facility: Luo He Central Hospital
state: Henan
city: Luohe
country: China
facility: WuYang People's Hospital
state: Henan
city: Luoyang
country: China
facility: Luo Yang Central Hospital
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of science and Technology
state: Henan
city: Luoyang
country: China
facility: The Second Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Nanyang
country: China
facility: Deng zhou People's Hospital
state: Henan
city: Pingdingshan
country: China
facility: First People's Hospital of Ping Dingshan
state: Henan
city: Pingdingshan
country: China
facility: General Hospital of Pingmei Shenma Group
state: Henan
city: Pingdingshan
country: China
facility: Lushan Xian People's Hospital
state: Henan
city: Pingdingshan
country: China
facility: Second People's Hospital of Ping Dingshan
state: Henan
city: Pingdingshan
country: China
facility: The 989 Hospital of the Chinese People's Liberation Army Joint Logistic Support Force
state: Henan
city: Puyang
country: China
facility: Puyang People's Hospital
state: Henan
city: Sanmenxia
country: China
facility: San Menxia Central Hospital
state: Henan
city: Sanmenxia
country: China
facility: Yellow River San Menxia Hospital
state: Henan
city: Shangqiu
country: China
facility: Central Hospital of Yongcheng
state: Henan
city: Shangqiu
country: China
facility: First People's Hospital of Shangqiu
state: Henan
city: Shangqiu
country: China
facility: Shangqiu Municipal Hospital
state: Henan
city: Shangqiu
country: China
facility: The People's Hospital of Yongcheng
state: Henan
city: Xinyang
country: China
facility: Tumor Hospital of Xinyang
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Sixth Peoples Hospital of Zhengzhou
state: Henan
city: Zhengzhou
country: China
facility: The Third Peoples Hospital of Zhengzhou
state: Henan
city: Zhoukou
country: China
facility: First People's Hospital of Zhoukou
state: Henan
city: Zhoukou
country: China
facility: Xihua Xian People's Hospital
state: Henan
city: Zhoukou
country: China
facility: Zhou Kou Central Hospital
state: Henan
city: Zhoukou
country: China
facility: Zhou Kou Hospital of TCM
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Xuhua Duan
role: PRINCIPAL_INVESTIGATOR
References: