primary hepatic carcinoma
Conditions
Interventions
experimental group:polyvinyl alcohol embolization microspheres loaded with anthracycline chemotherapeutic agents
Sponsors
Zhongda Hospital Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old = age = 80 years old, regardless of gender; 2. Patients with CNLC stage Ib to IIIa who are not suitable for/refused surgical resection, hepatocellular carcinoma transplantation and ablation therapy. 3. liver function classification Child-Pugh grade A or B. 4. physical status ECOG score = 2. 5. presence of at least 1 measurable tumor lesion (=7 cm in diameter) without embolization therapy. 6. agree to participate in this clinical trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. patients whose target lesion has been treated with embolization or whose target lesion requires combined ablation/radiotherapy with the first TACE treatment after enrollment. 2. those with diffuse or distant extensive tumor metastases and expected survival 176.8 µmol/L) 5. patients with significant reduction in blood leukocytes and platelets, with leukocytes < 3.0 x 10^9/L and platelets < 50 x 10^9/L (except for those with hypersplenism and chemotherapeutic bone marrow suppression) 6. uncorrectable coagulation dysfunction. 7. patients with severe infection who cannot be treated with TACE at the same time 8. complete embolization of the main trunk of the portal vein by cancer emboli. 9. Target lesion supply arteries that cannot be treated with TACE or are at risk of embolism (vascular access to normal areas, arteriovenous fistula, portal fistula, etc.) 10. patients with a history of bile-intestinal anastomosis and/or percutaneous hepatic percutaneous biliary drainage within the previous 1 year 11. Patients with known severe contrast allergy or allergy to embolic material 12. pregnant/lactating females, or those with family planning 13. patients who have participated in another drug or device clinical trial within 3 months 14. Patients who, in the opinion of the investigator, are otherwise unsuitable for participation in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate of 1 month after last DEB-TACE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of embolization of target lesion;Disease control rate of 1 month after the first DEB-TACE;Disease control rate of 1 month after last DEB-TACE;Disease control rate of 3 month after last DEB-TACE;Objective response rate of 1 month after the first DEB-TACE;Objective response rate of 1 month after last DEB-TACE;Times of DEB-TACE treatments for target lesions;Device performance evaluation; | — |
Countries
China
Contacts
Public ContactQi Zhang
Zhongda Hospital Southeast University
Outcome results
None listed