A Real-world Study of the Short-term Efficacy and Safety of E-TACE in Patients With Hepatocellular Carcinoma (HCC)
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| ClinicalTrials.gov Identifier: NCT06023147 |
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Recruitment Status :
Not yet recruiting
First Posted : September 5, 2023
Last Update Posted : September 7, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatocellular Carcinoma | Procedure: E-TACE | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated 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) |
| Estimated Study Start Date : | September 10, 2023 |
| Estimated Primary Completion Date : | September 10, 2024 |
| Estimated Study Completion Date : | September 10, 2025 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
- 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
- 6/12 months progression-free survival (PFS) rate [ Time Frame: 6/12 months ]Rate of progression free survival in 6/12 months
- 6/12 months overall survival (OS) rate [ Time Frame: 6/12 months ]Rate of over survival rate in 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 ]Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06023147
| Contact: Xuhua Duan | +8613523402912 | xuhuaduan@163.com | |
| Contact: Xinwei Han | 13803842129 | zzudxh@yeah.net |
Show 27 study locations
| Principal Investigator: | Xuhua Duan | The First Affiliated Hospital of Zhengzhou University |
| 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: | September 5, 2023 Key Record Dates |
| Last Update Posted: | September 7, 2023 |
| Last Verified: | September 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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E-TACE |
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Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |