Primary hepatic carcinoma
Conditions
Interventions
Experimental group:Developing embolic microspheres + epirubicin
Sponsors
Lishui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)18 years old = age =75 years old, gender is not limited (2) Patients with stage Ia to Ilb liver cancer who require transarterial chemoembolization (TACE) and are not suitable for or refuse surgical resection, liver transplantation, and ablation (3) Liver function classification Child-Pugh A or B (4) ECOG score of the patient's physical status = 2 points (5) Patients with measurable target lesions without embolization, with the maximum diameter of each target lesion =5cm and the number of target lesions =3 (6) Those who agree to participate in the clinical study and voluntarily sign the informed consent
Exclusion criteria
Exclusion criteria: (1) Patients with target lesions who had previously received embolization therapy or target lesion TACE therapy combined with ablation/local radiotherapy after admission (2) Patients with diffuse or distant liver tumors (3) Patients who had previously received immunotherapy or required combined immunotherapy/targeted therapy after enrollment (4) Patients with bad fluid or multiple organ failure (5) Patients with severe liver dysfunction (Child-PughC level of liver function) and renal dysfunction (serum creatinine >2mg/dl) (6) Patients with significant reduction of leukocytes and platelets (leukocytes <3.0x10/L, platelets <50x10/L) and can not be corrected (except patients with hyplenism and chemotherapy myelosuppression) (7) Patients with coagulation disorders that cannot be corrected (8) Patients with severe infection or severe active hepatitis who cannot be treated with TACE simultaneously (9) The main portal vein was completely embolized by cancer thrombus and no collateral blood supply was established (10) Patients with the risk of ectopic embolization (uncorrectable arteriovenous fistula and portal fistula) in the blood supply arteries of the target lesion (11) Patients with tumors accounting for more than 70% of the total liver (12) Known allergy to iodine-containing contrast media or polyvinyl alcohol embolization materials or epirubicin (13) Patients with CT or MRI contraindications (14) Patients with other serious diseases (such as serious cardiovascular and cerebrovascular diseases, respiratory diseases, metabolic diseases, etc.) resulting in the inability to perform TACE treatment and evaluation (15) Pregnant/lactating women (16) Patients who are participating in clinical trials of other drugs or devices (17) Patients considered by the investigator to be unsuitable for participating in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of device-related adverse events during the study period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Target lesion activity 1 month after TACE treatment;Embolization success rate of target lesion;Visual score of embolization area;Embolization success rate of target lesion; | — |
Countries
China
Contacts
Public ContactJianfei Tu
Lishui Central Hospital
Outcome results
None listed