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

• Status: Completed
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Sorafenib

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