Primary liver cancer
Conditions
Interventions
Experimental group:Radiopaque embolic bead
Control group:Pva embolized microspheres
Sponsors
Zhongshan Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female of age =18 and =80 years; 2. Patients with primary liver cancer meeting one of the following conditions: a) Patients with CNLC stage ?a, ?b and ?a who are unable or unwilling to undergo surgical resection or ablative treatment; b)Patients with CNLC ?b, ?a stage; 3. Child-Pugh A/B liver function; 4. ECOG Performance Status 0 ,1 or 2; 5. The patient had at least one measurable tumor lesion without embolization (maximum diameter of the target lesion =10cm); 6. Those who agree to participate in the clinical trial and voluntarily sign the informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who had previously received embolization therapy for the target lesion or required combined ablation/radiotherapy for the first TACE treatment of the target lesion after enrollment; 2. Severe liver dysfunction (Child-Pugh grade C); 3. Uncorrected coagulation dysfunction; 4. The main portal vein is completely embolized by cancer thrombus/thromboembolism, and collateral blood vessels are less formed (except for liver cancer patients who can restore portal blood flow through portal vein stents); 5. Severe infection or combination of active hepatitis; 6. Extrahepatic metastasis; 7. Estimated survival time 2mg/dl; 12. Patients diagnosed with Intrahepatic Cholangiocarcinoma; 13. Severe iodine contrast allergy; 14. Patients with a history of bilioenteric surgery within the past 1 year; 15. Pregnant/lactating women, or have a family plan; 16. Patients who have participated in clinical trials of other drugs or devices within 3 months; 17. Other patients deemed unsuitable for this clinical trial by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate of target lesions 1 month after the last TACE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate of target lesions 1 month after the first TACE and 3 months after the last TACE;Objective response rate of target lesions 1 month after the first TACE, 1 month and 3 months after the last TACE;The number of TACE treatments for target lesions;Embolization success rate of target lesion;All-cause mortality of subjects during the study period;Incidence of device-related adverse events during the study period; | — |
Countries
China
Contacts
Public ContactYan Zhiping
Zhongshan Hospital of Fudan University
Outcome results
None listed