efficacy and safety of tace on downstaging hepatocellular carcinoma beyond ucsf criteria;

Conditions: Hepatocellular Carcinoma

Summary: this is a multicenter, randomized, parallel controlled study to determine the efficacy and safety of transcatheter arterial chemoembolization (tace) on downstaging hepatocellular carcinoma beyond university of california, san francisco (ucsf) criteria.


Eligibility criteria:
inclusion criteria: 1. 18 to 70 years of age, of any sex; 2. patients who have histopathological or cytological proof of hepatocellular carcinoma (hcc) or meet the diagnostic criteria of diagnosis, management, and treatment of hepatocellular carcinoma(v2017); 3. beyond ucsf criteria: diameter of single hcc lesion is between 6.5 cm and 10 cm; the number of tumors ≤3 with the maximum diameter of 4.5-5cm and the total diameter ≤10cm; multiple hcc lesions ≤5 nodules, each lesion diameter≤4 cm with a total diameter ≤10 cm. patients cannot be treated with resection or liver transplantation; 4. patients with stage ib，iia，iib in china liver cancer staging (cnlc) ; 5. child-pugh's grade a or b (no more than 7 score); 6. eastern cooperative oncology group (ecog) performance status (ps) score of 0-1; 7. patients with hepatitis b virus (hbv) infection should receive routine antiviral therapy; 8. the function of main organs is normal and meet the following criteria: 1) outcome of blood routine must meet the following criteria (no blood transfusion or blood products were performed within 4 days, and no g-csf or other hematopoietic stimulants were used for correction): i. hemoglobin(hb)≥90 g/l; ii. absolute neutrophil count (anc)≥1.5×109/l； iii. platelet (plt)≥80×109/l; 2) outcome of hemal biochemistry examination meet the following criteria: i. albumin (alb) ≥29 g/l; ii. alanine aminotransferase (alt) and aspartate aminotransferase (ast)\ 45 ml/min (cockcroft-gault formula); 3) patients who have normal livers with an remnant liver volume (rlv)/standard liver volume(slv) \>20% ; patients who have cirrhosis with an rlv/slv\>40%; 9. life expectancy of \> 3 months; 10. patients volunteered to participate in this study and signed informed consent, with good compliance.exclusion criteria. exclusion criteria: 1. patients with extrahepatic metastasis or main portal vein /main hepatic vein invasion; 2. patients with diffuse liver cancer; 3. patients with myocardial ischemia, myocardial infarction or poor controlled arrhythmia (including qtc≥470 ms) beyond stage ⅱ; according to new york heart association (nyha) standard, patients with heart failure in stage ⅲ～ⅳ; patients with an left ventricular ejection fraction(lvef) \<50%; 4. abnormal coagulation （international normalized ratio(inr)\>1.5, prothrombin time(pt)\>uln+4s or activated partial thromboplastin time (aptt) \>1.5 ×uln）,or patients with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 5. patients unsuitable for the study in the opinion of the investigator; 6. pregnant or breastfeeding women; women of childbearing ages unless using effective contraception; 7. patients with mental disorders or history of abuse of psychotropic substances; 8. infection with human immunodeficiency virus (hiv); 9. a history of liver resection, liver transplantation, interventional therapy, or combined with other malignant tumors; 10. patients with active infection; 11. patients with contraindications to tace or epirubicin; 12. floating population or with poor compliance; 13. patients in other clinical trials conducting with experimental-related drugs or devices within 4 weeks.

Keywords: hepatocellular carcinoma