Hepatocellular Carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Understand and sign the informed consent approved by ethics committee 2. Aged 18 to 75 years male or female; 3. Confirmed diagnosis of HCC according to the diagnostic criteria included in the management guideline issued by China's Ministry of Health in 2017; 4. Conform to cTACE resistance standard of HCC 5. Single tumor less than 10cm in diameter or multiple tumors with maximum 5 lesions with >1cm in diameter, individual diameter <5cm; 6. Preserved liver function (Child-Pugh A or B7); 7. ECOG Performance Status 0 or 1.
Exclusion criteria
Exclusion criteria: 1. With arteriovenuous fistula or artery-portal vein fistula; 2. Diffuse HCC with defined as >50% liver involvement; 3. Any contraindication for TACE treatment; 4. Any contraindication for Epirubicin application; 5. Advanced liver disease (bilirubin levels >2 mg/dl, AST or ALT >5 times upper limit of normal); 6. Renal failure or insufficient renal function (Creatinine levels >2 mg/dl); 7. Subject unable to receive MRI examination; 8. Pregnant or breast feeding woman, or plan to become pregnant during treatment or within 12 months of treatment; 9. Couldn't commit reliable birth control measures during treatment or within 12 months of treatment; 10. Subject is participating other investigational drug or device clinical trial; 11. Subject is not suitable to participate in the study as judged by investigator; 12. With history of DEB-TACE for HCC.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TTP (time-to-progression); | — |
Secondary
| Measure | Time frame |
|---|---|
| OS (overall survival);DCR;ORR; | — |
Countries
China
Contacts
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University