NCT05121571CompletedNot Applicable
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
Sun Yat-sen University1 site in 1 country114 target enrollmentStarted: April 21, 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- Progression free survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
HAIC of FOLFOX
Experimental
Retreatment With hepatic arterial infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin
Intervention: HAIC (Procedure)
Sorafenib
Active Comparator
Intervention: Sorafenib (Drug)
Outcomes
Primary Outcomes
Progression free survival
Time Frame: 12 months
Secondary Outcomes
- tumor response(6 months)
- Number of Adverse Events(30 days)
- overall survival(24 months)
Investigators
Shi Ming
Proffessor
Sun Yat-sen University
Study Sites (1)
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