hepatocellular carcinoma
Conditions
Interventions
Group A:Drug-loaded irinotecan microsphere
Group B:epirubicin embolization microspheres
Sponsors
Shaanxi Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
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. Single tumor less than 10cm in diameter or multiple tumors with maximum 10 lesions, individual diameter <6cm; 5. Preserved liver function (Child-Pugh A or B7) OR ALBI grade 1/2; 6. ECOG Performance Status 0 or 1.
Exclusion criteria
Exclusion criteria: 1. Presence of macrovascular invasion of portal vein or hepatic vein or extra-hepatic spread of disease; 2. With arteriovenuous fistula or artery-portal vein fistula; 3. Diffuse HCC with defined as >50% liver involvement; 4. Any contraindication for TACE treatment; 5. Any contraindication for Epirubicin or Irinotecan application; 6. Advanced liver disease (bilirubin levels >2 mg/dl, AST or ALT >5 times upper limit of normal); 7. Renal failure or insufficient renal function (Creatinine levels >2 mg/dl); 8. Subject unable to receive MRI examination; 9. Pregnant or breast feeding woman, or plan to become pregnant during treatment or within 12 months of treatment; 10. Couldn't commit reliable birth control measures during treatment or within 12 months of treatment; 11. Subject is participating other investigational drug or device clinical trial; 12. Subject is not suitable to participate in the study as judged by investigator; 13. With history of DEB-TACE for HCC.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TTP (time-to-progression); | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS; | — |
Contacts
Public ContactZhubin Li
Shaanxi Cancer Hospital
Outcome results
None listed