The Efficacy and Safety of HAIC With FOLFOX vs Sorafenib for Patients Who Showed TACE-resistant: a Retrospective Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: HAIC
* Drug: Sorafenib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HAIC of FOLFOX<br>Retreatment With hepatic arterial infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin | Procedure: HAIC<br>* administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries<br>|
| Active Comparator: Sorafenib<br> | Drug: Sorafenib<br>* sorafenib 400mg bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | 30 days | 
| overall survival |  | 24 months | 
| tumor response | RECIST 1.1 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma, TACE failure, Sorafenib, Hepatic arterial infusion chemotherapy, Oxaliplatin, fluorouracil, and leucovorin