Neo-TACE-HAIC for BCLC B Stage HCC

Not Applicable

Recruiting

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

• Registration Number: NCT04424043
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-06
• Study First Submitted QC: 2020-06-06
• Study First Posted: 2020-06-09
• Study Start: 2020-07-08
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-22
• Last Update Posted: 2020-10-26
• Primary Completion: 2022-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgery alone	Surgery alone	hepatic resection remove the liver tumors
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

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