Clinical trial · Interventional
The Efficacy and Safety of HAIC With FOLFOX vs Sorafenib for Patients Who Showed TACE-resistant: a Retrospective Study
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HAIC | Procedure | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HAIC of FOLFOX
- description
- Retreatment With hepatic arterial infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin
- interventionNames
- Procedure: HAIC
- type
- ACTIVE_COMPARATOR
- label
- Sorafenib
- interventionNames
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 12 months
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHuang Y, Zhang L, He M, Lai Z, Bu X, Wen D, Li Q, Xu L, Wei W, Zhang Y, Zhou Z, Chen M, Guo R, Shi M, Kan A. Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Versus Sorafenib for Hepatocellular Carcinoma Refractory to Transarterial Chemoembolization: Retrospective Subgroup Analysis of 2 Prospective Trials. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221117389. doi: 10.1177/15330338221117389. PMID 36529949