TACE Combined With RFA/MV Treatment in Hepatocellular Carcinoma Beyond Milan Criterial

Clinical Trial of Transcatheter Arterial Chemoembolization Combined With Radiofrequency/Microwave Ablation in Hepatocellular Carcinoma Beyond Milan Criterial

This study was designed to evaluate the effectiveness of radiofrequency /microwave ablation in patients with hepatocellular carcinoma beyond Milan Criteria.

The aim of this study is to included 120 patients with intermediate stage hepatocellular carcinoma beyond Milan criteria .These patients were randomizedly allocated to TACE treatment group or TACE+RFA/MV .The treatment effectiveness, local tumor control and survival outcome between the two groups were compared.

Inclusion Criteria:

• patients diganosed with hepatocellualr carcinoma beyond Milan criteria
• the presence of a single HCC tumor ≤7 cm in diameter, or multi-nodular HCC tumors (n ≤ 5) small than 7 cm in diameter;
• Child-Pugh A or B
• ECOG score 0-1;
• prothrombin time ≤16 s;
• white cell count ≥3,000/mm3, platelet count ≥40 x 109/L;Hb≥8.5 g/d; ALT/AST≤5×ULN;TB≤3mg/dl;alb≥2.8 g/dl ;Scr ≤2mg/dl

Exclusion Criteria:

• expected survival time < 12 months before random assignment;
• received anticancer surgery or procedure within one month before assignment;
• concomitant use of any other anticancer therapy(except immunotherapy and herbal medicine ) ;
• existence of portal of hepatic vein invation or extrahepatic metastases;existence of active infection ;
• upper gastrointestinal hemorrhage within one month ; .other serious illness or medical condition.