Clinical trial · Observational
CECT Features of MVI Predict Response to TACE Plus TKI in Intermediate-stage HCC
Contrast-enhanced Computed Tomography Features of Microvascular Invasion Predict Response to Transarterial Chemoembolization Plus Tyrosine Kinase Inhibitor in Intermediate-stage Hepatocellular Carcinoma
NCT07449065CI-TRIAL-00104544completedClinicalTrials.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)
This retrospective multicenter study aims to evaluate whether radiographic microvascular invasion (MVI) status can predict treatment response in patients with intermediate-stage hepatocellular carcinoma (HCC) receiving transarterial chemoembolization (TACE) combined with tyrosine kinase inhibitors (TKIs) versus TACE alone.
Conditions
Conditions (4)
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 (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Microvascular Invasion (MVI) | — | UNRESOLVED | — |
| Transarterial Chemoembolization | — | UNRESOLVED | — |
| Tyrosine Kinase Inhibitors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TACE | Procedure | — | UNRESOLVED |
| TKI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- TACE group
- description
- Patients with intermediate-stage hepatocellular carcinoma who received TACE monotherapy. TACE procedures included conventional TACE and drug-eluting bead TACE, performed by experienced interventional radiologists. Conventional TACE involved infusion of a solution containing doxorubicin (75 mg) or epirubicin (50 mg) mixed with lipiodol, followed by embolization with gelatin sponge or polyvinyl alcohol foam particles. Drug-eluting bead TACE used DC Bead or Calispheres microspheres (100-300 or 300-500 μm) loaded with doxorubicin (75 mg) or epirubicin (50 mg). The endpoint of primary chemoembolization was complete HCC devascularization as observed on angiograms.
- interventionNames
- Procedure: TACE
- label
- TACE-TKI group
- description
- Patients with intermediate-stage hepatocellular carcinoma who received transarterial chemoembolization (TACE) combined with tyrosine kinase inhibitors (TKIs). TACE procedures included conventional TACE and drug-eluting bead TACE, performed by experienced interventional radiologists. Conventional TACE involved infusion of a solution containing doxorubicin (75 mg) or epirubicin (50 mg) mixed with lipiodol, followed by embolization with gelatin sponge or polyvinyl alcohol foam particles. Drug-eluting bead TACE used DC Bead or Calispheres microspheres (100-300 or 300-500 μm) loaded with doxorubicin (75 mg) or epirubicin (50 mg). TKI treatment included sorafenib (administered orally 400 mg twice daily) or lenvatinib (administered orally 8 mg/day for patients \<60 kg or 12 mg/day for patients ≥60 kg), with dose adjustments or interruptions based on treatment-related toxicities.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:(1) age 18-75 years; (2) primary intermediate-stage HCC diagnosed according to the European Association for the Study of the Liver/American Association for the Study of Liver Diseases criteria; (3) pretreatment CECT showing two to three lesions, with at least one \>3 cm, or more than three lesions of any size, without macrovascular invasion or extrahepatic metastasis; all lesions measurable per the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria; (4) Child¬-Pugh class A or B; (5) Eastern Cooperative Oncology Group performance status score of 0; (6) adequate hematologic and renal function (neutrophils ≥1.5×109/L, platelets ≥50×109/L, hemoglobin ≥90 g/L, serum albumin ≥30 g/L, total bilirubin ≤50 µmol/L, creatinine \<1.5× upper limit of normal); and (7) first-line local treatment with TACE, with or without sorafenib or lenvatinib.
References
Publications (0)
Data not yet available
No reference posted for this study.