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Neo-TACE-HAIC for High-risk BCLC A Stage HCC (NeoconceptA)

Neo-TACE-HAIC for High-risk BCLC A Stage HCC (NeoconceptA)

Recruiting
18-75 years
All
Phase N/A

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Overview

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

Study details
    Hepatocellular Carcinoma

NCT04777942

Sun Yat-sen University

27 January 2024

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