Clinical trial · Interventional
Neoadjuvant HAIC for Resectable Hepatocellular Carcinoma Beyond Milan Criteria
The Efficacy and Safety of Resection Plus Neoadjuvant Hepatic Arterial Infusion Chemotherapy Compared With Resection Alone in Patients With Resectable Hepatocellular Carcinoma Beyond Milan Criteria
NCT03469479CI-TRIAL-00034099unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the efficacy and safety of resection plus neoadjuvant hepatic arterial infusion chemotherapy (HAIC) compared with resection alone in patients with resectable hepatocellular carcinoma beyond Milan criteria.
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 |
|---|---|---|---|
| FOLFOX | Drug | FOLFOX Regimen | ALIAS |
| Hepatic resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Resection plus HAIC with FOLFOX
- description
- Patients receive 4 times of neoadjuvant hepatic arterial infusion chemotherapy with FOLFOX and hepatic resection
- interventionNames
- Drug: FOLFOX
- Procedure: Hepatic resection
- type
- ACTIVE_COMPARATOR
- label
- Resection
- description
- Patients receive hepatic resection without neoadjuvant hepatic arterial infusion chemotherapy
- interventionNames
- Procedure: Hepatic resection
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL; * Tumor burden beyond Milan criteria * Diagnosed as resectable with consensus by the panel of liver surgery experts; * No past history of resection, radiofrequency ablation, TACE, TAI, chemotherapy or molecule-targeted treatment; * No Cirrhosis or cirrhotic status of Child-Pugh class A only; * Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin ≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine ≤ 1.5 x upper limit of normal;(g) INR \> 2.3 or PT/APTT within normal limits; (h) Absolute neutrophil count (ANC) \>1,500/mm3; * Ability to understand the protocol and to agree to and sign a written informed consent document. Exclusion Criteria; * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * Known history of HIV * History of organ allograft * Known or suspected allergy to the investigational agents or any agent given in association with this trial. * Evidence of bleeding diathesis. * Any other hemorrhage/bleeding event \> CTCAE Grade 3 * Serious non-healing wound, ulcer, or bone fracture * Known central nervous system tumors including metastatic brain disease * Poor compliance that can not comply with the course of treatment and follow up.
References
Publications (0)
Data not yet available
No reference posted for this study.