Neo-TACE-HAIC for BCLC B Stage HCC

NCT04424043 | Unknown

• 1 other identifier: B2020-127
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

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 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%

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, MD.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiliang Qiu, MD.

CONTACT

862087343114; qiujl@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: June 6, 2020
• First Posted: June 9, 2020
• Study Start: July 8, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2025
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)