Hepatocellular carcinoma
Conditions
Interventions
Experimental group:DEB-TACE(Drug-eluting beads transcatheter arterial chemoembolization) plus targeted drugs
Control group:Targeted drugs
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with HCC diagnosed clinically or pathologically according to the Code for diagnosis and treatment of Primary liver Cancer (2019 Edition); 2. It was defined as intermediate stage according to BCLC staging before cTACE treatment, (multiple lesions in the liver, more than 3 or the longest diameter of the largest lesions was larger than 3 cm, without vascular invasion and distant metastasis); 3. cTACE refractory; 4. At least one measurable lesion; 5. Child-Pugh = 12 weeks; 8. Women of childbearing age or male patients whose sexual partners are women of childbearing age should take effective contraceptive measures during the whole treatment period and 6 months after the last medication; 9. Sign the informed consent form, and be able to comply with the requirements of the program and the family members agree to participate in the clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma diagnosed by histology/cytology; 2. A history of hepatic encephalopathy or a history of liver transplantation; 3. Pleural effusion, ascites and pericardial effusion that need to be drained with clinical symptoms; 4. Central system metastasis; 5. Tumor thrombus of the main portal vein involves both the branches of the contralateral portal vein or the superior mesenteric vein; tumor thrombus of the inferior vena cava; 6. Severe bleeding tendency or coagulation dysfunction and cannot be corrected(international standardized ratio 140 mmHg or diastolic blood pressure > 90 mmHg after treatment, hypertensive crisis or history of hypertensive encephalopathy; 11. Severe infection that is active or poorly controlled clinically; 12. Severe liver dysfunction: such as total bilirubin > 3.0 mg/dL, transaminase 5 times higher than the normal upper limit, refractory ascites, hepatic encephalopathy or hepatorenal syndrome; 13. Severe renal dysfunction: serum creatinine > 2 mg/dl or creatinine clearance < 30 ml/min; 14. Strong allergy to iodine contrast agent or previous history of allergic shock associated with contrast agent; 15. Diffuse hepatocellular carcinoma and bilobar tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS(Progress free survival); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rates;OS(Overall survival);AEs(Adverse events); | — |
Countries
China
Contacts
Public ContactCai-Fang Ni
The First Affiliated Hospital of Soochow University
Outcome results
None listed