Neo-TACE-HAIC for High-risk BCLC A Stage HCC (NeoconceptA)
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About
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.
Enrollment
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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
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• With unresectable HCC
- Pregnant woman or sucking period;
- With other malignant cancer;
- Received anti-HCC therapy before this study
Trial design
Primary purpose
Allocation
Interventional model
Masking
320 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Jiliang Qiu; Xuzhi Pan
Data sourced from clinicaltrials.gov
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