- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05121571
The Efficacy and Safety of HAIC With FOLFOX vs Sorafenib for Patients Who Showed TACE-resistant: a Retrospective Study
November 16, 2021 updated by: Shi Ming, Sun Yat-sen University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Cancer Center Sun Yat-sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sorafenib
|
sorafenib 400mg bid
|
Experimental: HAIC of FOLFOX
Retreatment With hepatic arterial infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin
|
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression free survival
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Adverse Events
Time Frame: 30 days
|
30 days
|
|
overall survival
Time Frame: 24 months
|
24 months
|
|
tumor response
Time Frame: 6 months
|
RECIST 1.1
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 21, 2016
Primary Completion (Actual)
December 12, 2018
Study Completion (Actual)
May 1, 2021
Study Registration Dates
First Submitted
November 14, 2021
First Submitted That Met QC Criteria
November 14, 2021
First Posted (Actual)
November 16, 2021
Study Record Updates
Last Update Posted (Actual)
November 26, 2021
Last Update Submitted That Met QC Criteria
November 16, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Sorafenib
Other Study ID Numbers
- SH-4
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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