RecruitingNot ApplicableNCT04777942

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

Neoadjuvant Transartery Chemoembolization Plus Artery Infusion Chemotherapy With Surgery Versus Surgery Alone for Hepatocellular Carcinoma Patients With High-risk Barcelona Clinic Liver Cancer (BCLC) A Stage: a Randomized Clinical Trial

Sponsor

Sun Yat-sen University

Enrollment

320 participants

Start Date

Feb 20, 2021

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving two types of liver-directed treatments — TACE (chemotherapy delivered directly into the liver's blood supply) and HAIC (a continuous infusion of chemotherapy into the liver artery) — before surgery can improve outcomes in people with a specific type of liver cancer (hepatocellular carcinoma, or HCC) that is technically removable but at high risk of coming back. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with BCLC stage A liver cancer with high-recurrence risk features - Your liver cancer is considered surgically removable - Your liver function is classified as Child-Pugh A or B (7 points) — meaning your liver is still working reasonably well - You have enough healthy liver remaining (more than 30%) after planned surgery **You may NOT be eligible if...** - Your cancer is not resectable (not removable by surgery) - You are pregnant or breastfeeding - You have another active cancer - You have already received prior anti-cancer treatment for this HCC Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREneo-TACE-HAIC+Surgery

transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h +5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection

PROCEDURESurgery alone

hepatic resection remove the liver tumors