Liver cancer
Conditions
Interventions
Experimental group:Vispearl can develop drug-carrying microspheres and chemotherapeutics
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 1cm in diameter, the single diameter was <7cm, and the total diameter was less than 10cm. 7. 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 had previously received local treatment (interventional embolization, radiotherapy, ablation) or first TACE treatment of target lesions combined with ablation/radiotherapy after admission; 2. Patients with extrahepatic metastasis; 3. Diffuse hepatocellular carcinoma, defined as liver involvement of more than 50%; 4. There are patients with arteriovenous fistula and portal venous fistula; 5. Severe liver dysfunction (Child-Pugh grade C), including jaundice, hepatic encephalopathy, refractory ascites or hepatorenal syndrome; 6. Renal dysfunction: blood creatinine >176.8 µmol/L or creatinine removal rate 2 points, bad fluid or multiple organ failure; 12. Known severe allergy to contrast agents, iodine contrast agents or embolic materials; 13. Pregnant/lactating women, or those who plan to give birth; 14. Patients who are participating in clinical trials of other drugs or devices and have not been out of the group or have been out of the group for less than 1 month; 15. People with no decision-making ability or mental illness; 16. Other patients deemed unsuitable for this clinical trial by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate of target lesion 90 days after the first TACE (ORR-mRECIST evaluation); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) of target lesions 30 days after the first TACE and 30 days after on-demand TACE - mRECIST evaluation;sease control rate (DCR) of target lesions at 30 days after the first TACE, 30 days after the first TACE, and 90 days after the first TACE - mRECIST evaluation;Treatment effect of target lesion 30 days after the first TACE, 30 days after the first TACE, and 90 days after the first TACE (TE);Distribution rate of developed microspheres in target lesions;All-cause mortality;Tumor-related mortality;AFP reaction rate;Overall patient survival (OS);Progression-free survival (PFS);Time to disease progression (TTP); | — |
Countries
China
Contacts
Public ContactYan Zhiping
Zhongshan Hospital, Fudan University
Outcome results
None listed