Neo-TACE-HAIC for High-risk BCLC A Stage HCC (NeoconceptA)
NCT04777942
Summary
Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. Although resection was recommend for early stage (BCLC A stage) patients according to the BCLC (Barcelona clinical liver cancer) system, increasing studies suggested that preoperative transarterial therapy may decrease the recurrence risk for those with high-risk factors. However, the clinical value is still undertermined. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC. Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC would improve survival for BCLC A stage patients with high-risk factors is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.
Eligibility
Inclusion Criteria: * Age 18-75 years; * BCLC A stage with high-recurrence risk factor; * Patients with resectable primary hepatocellular carcinoma; * Child-Pugh A or B (7 score) liver function; * The volume of residual liver more than 30% Exclusion Criteria: * • With unresectable HCC * Pregnant woman or sucking period; * With other malignant cancer; * Received anti-HCC therapy before this study
Conditions4
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NCT04777942