Trials / Completed
CompletedNCT07449065
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 324 (actual)
- Sponsor
- First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Patients who received TACE plus TKIs were compared with those who received TACE alone. Radiographic MVI status was assessed using CT-based radiomics features. The primary outcome is overall survival. Secondary outcomes include time to progression, objective response rate, and safety. The study seeks to determine whether radiographic MVI can serve as a predictive marker to guide the selection of patients who may benefit from combination therapy.
Conditions
- Hepatocellular Carcinoma (HCC)
- Transarterial Chemoembolization
- Microvascular Invasion (MVI)
- Tyrosine Kinase Inhibitors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TKI | tyrosine kinase 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. |
| PROCEDURE | TACE | 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). |
Timeline
- Start date
- 2018-06-01
- Primary completion
- 2025-10-31
- Completion
- 2025-10-31
- First posted
- 2026-03-04
- Last updated
- 2026-03-04
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07449065. Inclusion in this directory is not an endorsement.