Clinical trial · Interventional
HAIC Plus Sorafenib Versus TACE Plus Sorafenibfor Advanced HCC
The Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Plus Sorafenib Compared With Transarterial Chemoembolization Plus Sorafenib in Patients With BCLC C Stage Hepatocellular Carcinoma
NCT02856126CI-TRIAL-00079047completedPhase 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 hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with BCLC stage hepatocellular carcinoma (HCC).
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HAIC Regimen | Drug | — | UNRESOLVED |
| Hepatic arterial infusion chemotherapy | Procedure | — | UNRESOLVED |
| Oral Sorafenib | Drug | Sorafenib | ALIAS |
| TACE regimen | Drug | — | UNRESOLVED |
| Transarterial chemoembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HAIC plus sorafenib
- description
- Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: HAIC Regimen Drug: Oral Sorafenib
- interventionNames
- Procedure: Hepatic arterial infusion chemotherapy
- Drug: HAIC Regimen
- Drug: Oral Sorafenib
- type
- ACTIVE_COMPARATOR
- label
- TACE plus sorafenib
- description
- Procedure/Surgery: Transarterial chemoembolization Drug: TACE regimen Drug: Oral Sorafenib
- interventionNames
- Procedure: Transarterial chemoembolization
- Drug: TACE regimen
- Drug: Oral Sorafenib
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * The diagnosis of BCLC C stage HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) * Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. * with no previous treatment * No Cirrhosis or cirrhotic status of Child-Pugh class A only * Not amendable to surgical resection ,local ablative therapy and any other cured treatment. * The following laboratory parameters: * Platelet count ≥ 75,000/µL * Hemoglobin ≥ 8.5 g/dL * Total bilirubin ≤ 30mmol/L * Serum albumin ≥ 30 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 * Ability to understand the protocol and to agree to and sign a written informed consent document Exclusion Criteria: * Main portal vein occlusion * 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. * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Evidence of bleeding diathesis. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug * Serious non-healing wound, ulcer, or bone fracture * Known central nervous system tumors including metastatic brain disease
References
Publications (0)
Data not yet available
No reference posted for this study.