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

NCT04777942 | Recruiting

• 1 other identifier: B2020-322
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall survival, OS

  60 months

Study Arms (2)

neo-TACE-HAIC with surgery

EXPERIMENTAL

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

surgery alone

ACTIVE COMPARATOR

hepatic resection remove the liver tumors

Procedure: Surgery alone

Interventions

neo-TACE-HAIC+Surgery PROCEDURE

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

neo-TACE-HAIC with surgery

Surgery alone PROCEDURE

hepatic resection remove the liver tumors

surgery alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• With unresectable HCC
• Pregnant woman or sucking period;
• With other malignant cancer;
• Received anti-HCC therapy before this study

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Yunfei Yuan

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiliang Qiu

CONTACT

862087343114; qiujl@sysucc.org.cn

Xuzhi Pan

CONTACT

862087343009; panxzh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 2, 2021
• Study Start: February 20, 2021
• Primary Completion: December 30, 2023
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)