Primary hepatic carcinoma
Conditions
Interventions
Experimental group:Iodized oil and anthracycline chemotherapeutic emulsion + polyvinyl alcohol embolized microspheres
Control group:Iodized oil and anthracycline chemotherapeutic emulsion + embolized microspheres
Sponsors
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 liver cancer from stage lb to stage Illa who require transarterial chemoembolization (TACE) and are not suitable for/refuse surgical resection, liver cancer transplantation or ablation; (3) Liver function grade Child-Pugh A or B; (4) ECOG score of the patient's physical status =2 points; (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 with target lesions who have previously received embolization therapy or who need combined ablative radiotherapy after the first TACE treatment of target lesions in the human group; (2) Patients with extensive distant metastasis and expected survival 2mg/dL); (5) Significant reduction of white blood cells and platelets in patients with white blood cells <3.0x 10^9/L and platelets < 50x 10^9/L (except patients with hyperplenism and chemotherapy myelosuppression) (6) uncorrectable coagulation dysfunction; (7) Patients with active hepatitis or severe infection who cannot be treated with TACE at the same time; (8) The main portal vein was completely embolized by cancer embolus; (9) The target lesion blood supply artery can not be TACE treatment or there is a risk of embolization (vascular access endangers normal areas, arteriovenous fistula, portal venous fistula, etc.); (10) Patients with uncontrolled diabetes or a history of bilioenteric surgery within the past 1 year; (11) Known severe hypersensitivity to contrast media or embolic materials; (12) Pregnant/lactating women, or those who plan to give birth; (13) Patients who have participated in clinical trials of other drugs or devices within 3 months; (14) Other patients deemed unsuitable for the clinical trial by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate of target lesions 1 month after the last TACE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Embolization success rate of target lesion;Disease control rate of target lesions 1 month after the first TACE and 3 months after the last TACE;Objective response rate of target lesion 1 month after the first TACE and 1 month and 3 months after the last TACE;Times of TACE treatments for target lesions;Mortality during the study period;Device performance evaluation; | — |
Countries
China
Contacts
Public ContactYinghua Zou
Peking University First Hospital
Outcome results
None listed