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NCT Number: NCT05121571

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HAIC

Procedure

administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Sorafenib

Drug

sorafenib 400mg bid

Primary outcomes

  1. Progression free survival

    Time frame: 12 months

Secondary outcomes

  1. Number of Adverse Events

    Time frame: 30 days

  2. overall survival

    Time frame: 24 months

  3. tumor response

    Time frame: 6 months

    RECIST 1.1

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2021
First posted
Nov 16, 2021
Registry last updated
Nov 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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