- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04777942
Neo-TACE-HAIC for High-risk BCLC A Stage HCC (NeoconceptA)
February 28, 2021 updated by: Yunfei Yuan, Sun Yat-sen University
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
320
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xuzhi Pan
- Phone Number: 862087343009
- Email: panxzh@sysucc.org.cn
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-sen University Cancer Center
-
Contact:
- Xuzhi Pan
- Phone Number: 862087343009
- Email: panxzh@sysucc.org.cn
-
Principal Investigator:
- Yunfei Yuan, MD.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: surgery alone
hepatic resection remove the liver tumors
|
hepatic resection remove the liver tumors
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival, OS
Time Frame: 60 months
|
OS was calculated from the date of starting treatment to the date of death.
|
60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 20, 2021
Primary Completion (Anticipated)
December 30, 2023
Study Completion (Anticipated)
December 30, 2026
Study Registration Dates
First Submitted
February 28, 2021
First Submitted That Met QC Criteria
February 28, 2021
First Posted (Actual)
March 2, 2021
Study Record Updates
Last Update Posted (Actual)
March 2, 2021
Last Update Submitted That Met QC Criteria
February 28, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2020-322
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkCompletedAdvanced Adult Hepatocellular Carcinoma | Localized Non-Resectable Adult Hepatocellular Carcinoma | Stage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular Carcinoma | Stage III... and other conditionsUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedUnresectable Hepatocellular Carcinoma | Advanced Adult Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma AJCC v7 | Stage IIIC Hepatocellular Carcinoma AJCC v7 | BCLC Stage C Hepatocellular Carcinoma | Stage IV Hepatocellular Carcinoma AJCC v7 | Stage III Hepatocellular Carcinoma AJCC... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedUnresectable Hepatocellular Carcinoma | Advanced Adult Hepatocellular Carcinoma | Recurrent Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma AJCC v7 | Stage IIIC Hepatocellular Carcinoma AJCC v7 | Stage IV Hepatocellular Carcinoma AJCC v7 | Stage III Hepatocellular Carcinoma AJCC v7 and other conditionsUnited States, Canada, Puerto Rico
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Mayo ClinicNational Cancer Institute (NCI)RecruitingAdvanced Hepatocellular Carcinoma | BCLC Stage B Hepatocellular Carcinoma | BCLC Stage C Hepatocellular Carcinoma | Metastatic Hepatocellular Carcinoma | BCLC Stage A Hepatocellular CarcinomaUnited States
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Northwestern UniversityBristol-Myers Squibb; National Cancer Institute (NCI)CompletedStage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular CarcinomaUnited States
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Sun Yat-sen UniversityRecruiting
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Sun Yat-sen UniversityRecruiting
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Sun Yat-sen UniversityRecruitingHepatocellular Carcinoma | Potentially ResectionChina
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Second Affiliated Hospital of Guangzhou Medical...First Affiliated Hospital, Sun Yat-Sen University; First People's Hospital... and other collaboratorsRecruiting
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Peking University Cancer Hospital & InstituteRecruitingAdvanced Hepatocellular Carcinoma (HCC)China
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Peking University Cancer Hospital & InstituteNot yet recruiting
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First Affiliated Hospital, Sun Yat-Sen UniversityNot yet recruitingLiver Metastasis Colon CancerChina
-
Peking University Cancer Hospital & InstituteNot yet recruitingHCC | Regorafenib | Transarterial Chemoembolization | Hepatic Arterial Infusion Chemotherapy
-
Sun Yat-sen UniversityRecruitingHepatocellular CarcinomaChina
-
Eastern Hepatobiliary Surgery HospitalCompletedHepatocellular CarcinomaChina