Neo-TACE-HAIC for BCLC B Stage HCC

Hepatocellular Carcinoma Clinical Trial

— NeoconceptB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04424043
• Other study ID #: B2020-127
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: December 30, 2025

Study information

• Verified date: October 2020
• Source: Sun Yat-sen University
• Contact: Jiliang Qiu, MD.
• Phone: 862087343114
• Email: qiujl[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• 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
hepatic resection remove the liver tumors

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival, PFS	PFS was calculated from the date of starting treatment to the date of progression, of disease or death	36 months
Secondary	Overall survival, OS	OS was calculated from the date of starting treatment to the date of death.	60 months