Neo-TACE-HAIC for BCLC B Stage HCC

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04424043

Acronym

NeoconceptB

Enrollment

280

Registered

2020-06-09

Start date

2020-07-08

Completion date

2025-12-30

Last updated

2020-10-26

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 BCLC (Barcelona clinical liver cancer) system recommend to transarterial chemoembolization (TACE) for BCLC B stage patients, increasing studies suggested that hepatic resection provided survival benefit for those patients. However, a relative high recurrence risk leads surgeons to investigate the value of preoperative treatment. 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 patients with BCLC B stage 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 B stage and tumor number \<=4; * 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, MD.

qiujl@sysucc.org.cn862087343114

Outcome results

None listed

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