Back to resultsNeo-TACE-HAIC for BCLC B Stage HCC (NeoconceptB)
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
neo-TACE-HAIC+Surgery
Surgery alone
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
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
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
neo-TACE-HAIC with surgery
surgery alone
Arm Description
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
hepatic resection remove the liver tumors
Outcomes
Primary Outcome Measures
Progression-free survival, PFS
PFS was calculated from the date of starting treatment to the date of progression, of disease or death
Secondary Outcome Measures
Overall survival, OS
OS was calculated from the date of starting treatment to the date of death.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04424043
Brief Title
Neo-TACE-HAIC for BCLC B Stage HCC
Acronym
NeoconceptB
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
neo-TACE-HAIC with surgery
Arm Type
Experimental
Arm Description
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
Arm Title
surgery alone
Arm Type
Active Comparator
Arm Description
hepatic resection remove the liver tumors
Intervention Type
Procedure
Intervention Name(s)
neo-TACE-HAIC+Surgery
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Surgery alone
Intervention Description
hepatic resection remove the liver tumors
Primary Outcome Measure Information:
Title
Progression-free survival, PFS
Description
PFS was calculated from the date of starting treatment to the date of progression, of disease or death
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Overall survival, OS
Description
OS was calculated from the date of starting treatment to the date of death.
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiliang Qiu, MD.
Phone
862087343114
Email
qiujl@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunfei Yuan, MD.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiliang Qiu, MD.
Phone
862087343114
Email
qiujl@sysucc.org.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Neo-TACE-HAIC for BCLC B Stage HCC
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