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

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: neo-TACE-HAIC+Surgery; Procedure: Surgery alone

• Registration Number: NCT04777942
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-02
• Study Start: 2021-02-20
• Study First Submitted: 2021-02-28
• Study First Submitted QC: 2021-02-28
• Last Update Submitted: 2021-02-28
• Study First Posted: 2021-03-02
• Last Update Posted: 2021-03-02
• Primary Completion: 2023-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
neo-TACE-HAIC with surgery	neo-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
surgery alone	Surgery alone	hepatic resection remove the liver tumors

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Overall survival, OS	60 months	OS was calculated from the date of starting treatment to the date of death.

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China