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

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05121571
• Collaborator: (none)
• Enrollment: 114
• Location: 1
• Arms: 2
• Actual Duration (Months): 60.3
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Procedure: HAIC; Drug: Sorafenib	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 21, 2016
• Actual Primary Completion Date: Dec 12, 2018
• Actual Study Completion Date: May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HAIC of FOLFOX Retreatment With hepatic arterial infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin	Procedure: HAIC; administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Active Comparator: Sorafenib	Drug: Sorafenib; sorafenib 400mg bid

Outcome Measures

Primary Outcome Measures

1. Progression free survival [12 months]

Secondary Outcome Measures

1. Number of Adverse Events [30 days]

2. overall survival [24 months]

3. tumor response [6 months]

   RECIST 1.1

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Center Sun Yat-sen University	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shi Ming, Proffessor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT05121571
• Other Study ID Numbers: SH-4
• First Posted: Nov 16, 2021
• Last Update Posted: Nov 26, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shi Ming, Proffessor, Sun Yat-sen University: Hepatocellular Carcinoma; TACE failure; Sorafenib; Hepatic arterial infusion chemotherapy; Oxaliplatin, fluorouracil, and leucovorin
• Additional relevant MeSH terms: Carcinoma, Hepatocellular; Sorafenib

Study Results

No Results Posted as of Nov 26, 2021