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NeoconceptB: Neo-TACE-HAIC for BCLC B Stage HCC

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04424043
Collaborator
(none)
280
Enrollment
1
Location
2
Arms
65.7
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
280 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 Barcelona Clinic Liver Cancer (BCLC) B Stage: a Randomized Clinical Trial
Actual Study Start Date :
Jul 8, 2020
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2025

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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:
No
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

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, MD., 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:
NCT04424043
Other Study ID Numbers:
  • B2020-127
First Posted:
Jun 9, 2020
Last Update Posted:
Oct 26, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular

Study Results

No Results Posted as of Oct 26, 2020