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 enrollmentApril 21, 2016

ConditionsHepatocellular Carcinoma

InterventionsHAIC Sorafenib

DrugsSorafenib

Overview

Phase: Not Applicable
Intervention: HAIC
Conditions: Hepatocellular Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 114
Locations: 1
Primary Endpoint: Progression free survival
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

April 21, 2016

End Date

May 1, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Shi Ming

Proffessor

Sun Yat-sen University

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