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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04777942

Collaborator

(none)

320

Enrollment

Location

Arms

70.3

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Procedure: neo-TACE-HAIC+Surgery Procedure: Surgery alone	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 20, 2021

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: neo-TACE-HAIC with 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	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
Active Comparator: surgery alone hepatic resection remove the liver tumors	Procedure: Surgery alone hepatic resection remove the liver tumors

Arm

Intervention/Treatment

Experimental: neo-TACE-HAIC with 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

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

Active Comparator: surgery alone

hepatic resection remove the liver tumors

Procedure: Surgery alone

hepatic resection remove the liver tumors

Outcome Measures

Primary Outcome Measures

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

Overall survival, OS [60 months]
OS was calculated from the date of starting treatment to the date of death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Principal Investigator: Yunfei Yuan, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yunfei Yuan, Professor, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT04777942

Other Study ID Numbers:

B2020-322

First Posted:

Mar 2, 2021

Last Update Posted:

Mar 2, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Mar 2, 2021