Hepatocellular Carcinoma
Conditions
Interventions
Control group:Lipiodol TACE
Sponsors
Xi'an International Medical Center Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Obtain the informed consent of the subjects; 2. Diagnosis of hepatocellular carcinoma: (1) Subjects with viral hepatitis or liver cirrhosis should be clinically diagnosed according to the AASLD criteria: that is, the subject has a history of viral hepatitis or liver cirrhosis, and the diagnosis should be confirmed in combination with imaging examinations (Enhanced CT, MRI and second-generation ultrasound contrast agents). When the tumor diameter is greater than 2cm, there is a typical imaging technique showing rapid enhancement in the arterial phase and rapid washout in the venous phase to confirm the diagnosis; if the diameter is 1-2cm, it needs to be confirmed by two imaging techniques or one imaging and alpha-fetoprotein>400ng/ml; (2) For subjects who cannot be clinically diagnosed, perform histological or cytological biopsy confirmation; the original biopsy records can also be used to confirm the diagnosis; 3. BCLCA stage and BCLC B stage for which curative treatment is infeasible and with moderate to high tumor burden (tumor size + tumor number > 6); 4. Child Pugh A/B (=9.0g/dl, neutrophils>=1,500/mm^3, PLT>=50x10^9/L, serum ALB>=28g/L, TBIL < 2 mg/dL, ALT, AST < 5 times the upper limit of normal, Bun, Cr < 1.5 times the upper limit of normal, INR < 1.7 or PT prolongation < 4s.
Exclusion criteria
Exclusion criteria: 1. Portal vein and any vascular invasion; 2. Distant metastasis of tumor; 3. The tumor invades the biliary tract or causes biliary obstruction; 4. Patients with known brain metastases or symptoms of brain metastases without further examination to exclude brain metastases; 5. Diffuse liver tumors, hypovascular tumors, and lesions with unclear capsule boundaries; 6. Known portosystemic shunt or hepatic vascular arteriovenous fistula; 7. Congestive heart failure > New York Heart Association (NYHA) grade 2; uncontrolled hypertension; 8. A history of human immunodeficiency virus (HIV) infection; 9. Renal failure or insufficient renal function, requiring blood or peritoneal dialysis; 10. Received any previous treatment; 11. Severe active clinical infection (> grade 2, NCI-CTCAE version 4.0), except HBV and HCV infection; 12. Upper gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding occurs within 12 weeks before the start of the test; 13. Any contraindications to doxorubicin/pirarubicin; 14. Patients who are breastfeeding; 15. Patients who have had major surgery (eg: intrathoracic, intra-abdominal or pelvic) within 3 weeks before starting the trial or patients who have not recovered from the side effects of such surgery; 16. Combined with other malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Time to progression;Progression-free survival;Safety;Time to response; | — |
Countries
China
Contacts
Public ContactHan Guohong
Xi'an International Medical Center Hospital/Northwestern University Affiliated Hospital
Outcome results
None listed