Hepatocellular carcinoma
Conditions
Interventions
DEB-TACE group:Doxorubicin-eluting beads (CalliSpheres) plus microspheres TACE
cTACE group:Conventional (microspheres plus lipiodo-doxorubicin) TACE
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Understand and sign the informed consent; 2. Aged 18-90 years men and women; 3. Clinical or pathological diagnosis of hepatocellular carcinoma(unresectable),target lesions without topical therapy have at least one measurable lesion(the tumor size is more than 10mm or lymph node more than 15mm according to mRECIST requirements); 4. BCLC stage was A or B stage; 5. The physical capacity of ECOG is less than 1; 6. The volume of tumor is less than 50% of the total liver volume; 7. The expected survival time is greater than 12 weeks.
Exclusion criteria
Exclusion criteria: 1. Child-Pugh level C; 2. Coagulation function is poor, the clotting time is significantly prolonged (>17.0s) and cannot be corrected; 3. Patients with obvious arteriovenous fistula suggested by DSA or medical-images; 4. Tumor load >50% or treated with liver transplantation; 5. Serum bilirubin over 51 µmol/L, AST and / or ALT >5 times the normal upper limit; 6. Patients with cardiac dysfunction and the left ventricular ejection fraction is less than 50%; 7. In past 3 months, patient has a history of clinically bleeding symptoms or tendency of bleeding, eg. hemoptysis 2. 5ml or more, gastrointestinal bleeding, esophageal varices with high risk, hemorrhagic gastric ulcer or vasculitis, etc. 8. In past 3 months, patient has a history of arteriovenous-shunt thrombosis, eg. stroke (temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism,etc. 9. Patients who can not be treated due to serious diseases, such as hepatapostema; 10. Patients with congenital or acquired immunodeficiency (eg.HIV infectors) 11. The patients had other malignant tumors in the past 3 years (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 12. The expected survival time is less than 3 months; 13. Complications or social environment that can lead the failure of the subjects to follow the study plan and even endanger the safety of the patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatic injury;Inflammation and hypoxia factors; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;PFS;DCR;6-month survival rate;12-month survival rate;OS; | — |
Countries
China
Contacts
Public ContactYin Guowen
Jiangsu Cancer Hospital
Outcome results
None listed