TACE-HAIC vs. HAIC for Potentially Resectable HCC
Primary Purpose
Potentially Resection, Hepatocellular Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TACE-HAIC
HAIC
Sponsored by
About this trial
This is an interventional treatment trial for Potentially Resection
Eligibility Criteria
Inclusion Criteria:
- Age 18-75 years
- The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
- Diagnosed as potentially resectable with consensus by the panel of liver surgeons
- stage BCLC A/B, without extra-hepatic involvement
- No previous anti-HCC treatment
- Eastern Co-operative Group performance status 2 or less
- Liver function: Child's A or B (score < 7)
Exclusion Criteria:
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- underlying serve cardiac or renal diseases
- Known or suspected allergy to the investigational agent or any agent given in association with this trial
- Patients ineligible for hepatic artery embolization
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TACE-HAIC
HAIC
Arm Description
hepatic artery chemo-lipiodolization with EADM, followed by FOLFOX-based chemotherapy artery infusion
FOLFOX-based chemotherapy hepatic artery infusion
Outcomes
Primary Outcome Measures
progression-free survival
Time to progression, last follow-up or death after random assignment to TACE-HAIC or HAIC
Secondary Outcome Measures
overall survival
time to death or last follow-up after random assignment to TACE-HAIC or HAIC
Downstage hepatectomy rate
The hepatectomy rate after TACE-HAIC or HAIC
Full Information
NCT ID
NCT03591705
First Posted
July 9, 2018
Last Updated
September 20, 2021
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03591705
Brief Title
TACE-HAIC vs. HAIC for Potentially Resectable HCC
Official Title
Transarterial Chemoembolization Versus Transarterial Chemoembolization With Hepatic Artery Chemotherapy Infusion for Patients With Potentially Resectable HCC
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2018 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (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) is one of the most commonly malignant tumors around the world. Hepatic resection or liver transplantation is the radical method to cure the disease. However, due to large tumors, surgical treatment is suitable for early-stage and well-reserved liver function patients. Therefore, in clinical practice, transarterial chemoembolization (TACE) is a preferential and standard treatment of potentially resectable HCC.
EACH trial opened the door to FOLFOX-based system chemotherapy for advanced HCC patients. Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for HCC patients. Several clinical studies showed that HAIC bring better tumor response rate that the conditional TACE. The combination of TACE with HAIC (TACE-HAIC), theoretically can significantly increase the local doses of chemotherapeutic agents in the liver, reduce the viability of HCC cells and increase the hepatectomy rate. However, this hasn't been verified in clinical application. To identify a more effective and safety way for treating potentially resectable HCC patients, this study is designed to compare the safety and efficacy between HAIC and TACE-HAIC for those patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Potentially Resection, Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TACE-HAIC
Arm Type
Experimental
Arm Description
hepatic artery chemo-lipiodolization with EADM, followed by FOLFOX-based chemotherapy artery infusion
Arm Title
HAIC
Arm Type
Active Comparator
Arm Description
FOLFOX-based chemotherapy hepatic artery infusion
Intervention Type
Drug
Intervention Name(s)
TACE-HAIC
Intervention Description
transcatheter arterial chemo-lipiodolization with EADM 30mg/m2, followed by hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2 infusion 23h.
Intervention Type
Drug
Intervention Name(s)
HAIC
Intervention Description
hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2 infusion 23h.
Primary Outcome Measure Information:
Title
progression-free survival
Description
Time to progression, last follow-up or death after random assignment to TACE-HAIC or HAIC
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
overall survival
Description
time to death or last follow-up after random assignment to TACE-HAIC or HAIC
Time Frame
6-12 months
Title
Downstage hepatectomy rate
Description
The hepatectomy rate after TACE-HAIC or HAIC
Time Frame
6-12 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
The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
Diagnosed as potentially resectable with consensus by the panel of liver surgeons
stage BCLC A/B, without extra-hepatic involvement
No previous anti-HCC treatment
Eastern Co-operative Group performance status 2 or less
Liver function: Child's A or B (score < 7)
Exclusion Criteria:
Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
underlying serve cardiac or renal diseases
Known or suspected allergy to the investigational agent or any agent given in association with this trial
Patients ineligible for hepatic artery embolization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiliang Qiu
Phone
+862087342654
Email
qiujl@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunfei Yuan
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
Yunfei Yuan
Phone
+862087343118
Email
yuanyf@mail.sysu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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TACE-HAIC vs. HAIC for Potentially Resectable HCC
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