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

Hepatocellular Carcinoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05121571
• Other study ID #: SH-4
• Status: Completed
• Phase: N/A
• Start date: April 21, 2016
• Est. completion date: May 1, 2021

Study information

• Verified date: November 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: May 1, 2021
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• HAIC
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Drug:
• Sorafenib
sorafenib 400mg bid

Locations

Country	Name	City	State
China	Cancer Center Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		12 months
Secondary	Number of Adverse Events		30 days
Secondary	overall survival		24 months
Secondary	tumor response	RECIST 1.1	6 months