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

Sun Yat-sen University logo

Sun Yat-sen University

Status

Completed

Conditions

Hepatocellular Carcinoma

Treatments

Procedure: HAIC
Drug: Sorafenib

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

114 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

114 participants in 2 patient groups

HAIC of FOLFOX
Experimental group
Description:
Retreatment With hepatic arterial infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin
Treatment:
Procedure: HAIC
Sorafenib
Active Comparator group
Treatment:
Drug: Sorafenib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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