CECT Features of MVI Predict Response to TACE Plus TKI in Intermediate-stage HCC

First Affiliated Hospital, Sun Yat-Sen University324 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

324

Conditions

Hepatocellular Carcinoma (HCC)Transarterial Chemoembolization Microvascular Invasion (MVI)Tyrosine Kinase Inhibitors

Interventions

TKIDRUG

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.

TACEPROCEDURE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Overall survival

Time interval from date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months

Time frame: From date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcomes

Progression-free survival

Time interval from date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Time frame: From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Tumor response

Defined as the proportion of patients achieving complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) according to mRECIST criteria.

Time frame: From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.