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

Recruiting now · Not applicable

Conditions studied: Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT04777942

Run by

Sun Yat-sen University

People needed

320

Starts

2021-02-20

Expected to finish

2026-12-30

Last updated by the study team

2021-03-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• • With unresectable HCC
• Pregnant woman or sucking period;
• With other malignant cancer;
• Received anti-HCC therapy before this study

Where it is running

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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