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

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: HAIC; Drug: Sorafenib

• Registration Number: NCT05121571
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-21
• Primary Completion: 2018-12-12
• Study Completion: 2021-05-01
• Status Verified: 2021-11
• Study First Submitted: 2021-11-14
• Study First Submitted QC: 2021-11-14
• Study First Posted: 2021-11-16
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HAIC of FOLFOX	HAIC	Retreatment With hepatic arterial infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin
Sorafenib	Sorafenib	-

Primary Outcome Measures

Name	Time	Method
Progression free survival	12 months

Secondary Outcome Measures

Name	Time	Method
tumor response	6 months	RECIST 1.1
Number of Adverse Events	30 days
overall survival	24 months

Trial Locations

Locations (1)

Cancer Center Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China