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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04777942
Recruitment Status : Recruiting
First Posted : March 2, 2021
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Yunfei Yuan, Sun Yat-sen University

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 20, 2021
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Progression-free survival, PFS [ Time Frame: 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 [ Time Frame: 60 months ]
    OS was calculated from the date of starting treatment to the date of death.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04777942


Contacts
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Contact: Jiliang Qiu 862087343114 qiujl@sysucc.org.cn
Contact: Xuzhi Pan 862087343009 panxzh@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Jiliang Qiu    862087343114    qiujl@sysucc.org.cn   
Contact: Xuzhi Pan    862087343009    panxzh@sysucc.org.cn   
Principal Investigator: Yunfei Yuan, MD.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Yunfei Yuan Sun Yat-sen University
More Information
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Responsible Party: Yunfei Yuan, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04777942    
Other Study ID Numbers: B2020-322
First Posted: March 2, 2021    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases