Back to resultsThe Efficacy and Safety of HAIC With FOLFOX vs Sorafenib for Patients Who Showed TACE-resistant: a Retrospective Study
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HAIC
Sorafenib
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, TACE failure, Sorafenib, Hepatic arterial infusion chemotherapy, Oxaliplatin, fluorouracil, and leucovorin
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with HCC according to the European Association for the Study of the Liver (EASL) diagnostic criteria
- TACE failure/refractoriness by Liver Cancer Study Group of Japan (LCSGJ) criteria
- Without extrahepatic metastasis
- The following laboratory parameters:
Platelet count ≥ 60,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
Exclusion Criteria:
- Known history of HIV
- History of organ allograft
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- Serious non-healing wound, ulcer, or bone fracture
- Evidence of bleeding diathesis.
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
Sites / Locations
- Cancer Center Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HAIC of FOLFOX
Sorafenib
Arm Description
Retreatment With hepatic arterial infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin
Outcomes
Primary Outcome Measures
Progression free survival
Secondary Outcome Measures
Number of Adverse Events
overall survival
tumor response
RECIST 1.1
Full Information
NCT ID
NCT05121571
First Posted
November 14, 2021
Last Updated
November 16, 2021
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT05121571
Brief Title
The Efficacy and Safety of HAIC With FOLFOX vs Sorafenib for Patients Who Showed TACE-resistant: a Retrospective Study
Official Title
The Efficacy and Safety of Retreatment With Hepatic Arterial Infusion Chemotherapy With Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib for Patients Who Showed Transarterial Chemoembolization-resistant: a Retrospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 21, 2016 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
May 1, 2021 (Actual)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Transarterial chemoembolization (TACE) is considered the gold standard for treating intermediate-stage hepatocellular carcinoma (HCC). However, any treatment guidelines do not specify the criteria for repeating TACE. This study was to compare HAIC with FOLFOX with sorafenib who showed TACE-resistant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, TACE failure, Sorafenib, Hepatic arterial infusion chemotherapy, Oxaliplatin, fluorouracil, and leucovorin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HAIC of FOLFOX
Arm Type
Experimental
Arm Description
Retreatment With hepatic arterial infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin
Arm Title
Sorafenib
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
HAIC
Intervention Description
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
sorafenib 400mg bid
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Adverse Events
Time Frame
30 days
Title
overall survival
Time Frame
24 months
Title
tumor response
Description
RECIST 1.1
Time Frame
6 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:
Diagnosed with HCC according to the European Association for the Study of the Liver (EASL) diagnostic criteria
TACE failure/refractoriness by Liver Cancer Study Group of Japan (LCSGJ) criteria
Without extrahepatic metastasis
The following laboratory parameters:
Platelet count ≥ 60,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
Exclusion Criteria:
Known history of HIV
History of organ allograft
Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Serious non-healing wound, ulcer, or bone fracture
Evidence of bleeding diathesis.
Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
Facility Information:
Facility Name
Cancer Center Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of HAIC With FOLFOX vs Sorafenib for Patients Who Showed TACE-resistant: a Retrospective Study
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