Primary hepatic carcinoma
Conditions
Interventions
Experimental group:Development embolization microspheres
Sponsors
Zhongda Hospital, Affiliated to Southeast University; Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) 18 years old = age =80 years old, gender is not limited (2) Patients with stage Ia to stage IIIa 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) The patient had measurable lesions that had not been embolized (if there were more than 3 lesions, the 3 lesions with the largest diameter were selected as target lesions, and the maximum diameter of a single target lesion was =10cm). (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 with an expected survival of 2mg/dl) (5) Patients with significant reduction of leukocytes and platelets (leukocytes < 3.0×10^9/L, platelets < 50×10^9/L, hemoglobin < 60g/L) and cannot be corrected (except patients with hyperplenism and chemotherapy myelosuppression) (6) Uncorrectable coagulation dysfunction (PT prolonged by more than 3 seconds above the upper limit of normal) (7) Patients with severe infection who cannot be treated with interventional therapy (more than five times the upper limit of normal white blood cells) (8) The main portal vein was completely embolized by cancer thrombus and no collateral blood supply was established (9) Patients with risk of ectopic embolization (uncorrected arteriovenous fistula and portal venous fistula) in the target lesion supplying arteries (10) Angiography shows that the vascular anatomy hinders catheterization or embolic injection or there is vasospasm, which is not suitable for TACE treatment (11) Known allergy to iodine-containing contrast agents or polyvinyl alcohol embolization materials or anthracycline chemotherapy drugs (12) Pregnant/lactating women (13) Patients who are participating in interventional clinical trials of other drugs or medical devices (14) Patients who are not considered suitable to participate in this clinical study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR) for target lesions 1 month after last TACE treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visualization score of embolic area;The success rate of embolization of target lesions;Equipment performance evaluation;ORR;Number of TACE treatments for target lesions;Disease control rate (DCR) of target lesions 1 month after the first TACE treatment and 3 months after the last TACE treatment; | — |
Countries
China
Contacts
Public ContactTenggaojun, Zouyinghua
Zhongda Hospital, Affiliated to Southeast University; Peking University First Hospital
Outcome results
None listed