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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04777942

Enrollment

320

Registered

2021-03-02

Start date

2021-02-20

Completion date

2026-12-30

Last updated

2021-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Brief 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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Progression-free survival, PFS	36 months	PFS was calculated from the date of starting treatment to the date of progression, of disease or death

Secondary

Measure	Time frame	Description
Overall survival, OS	60 months	OS was calculated from the date of starting treatment to the date of death.

Countries

China

Contacts

Primary ContactJiliang Qiu

qiujl@sysucc.org.cn862087343114

Backup ContactXuzhi Pan

panxzh@sysucc.org.cn862087343009

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026