Hepatocellular Carcinoma (HCC), Transarterial Chemoembolization, Microvascular Invasion (MVI), Tyrosine Kinase Inhibitors
Conditions
Keywords
HCC, TACE, MVI, TKI
Brief 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.
Interventions
DRUGTKI
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.
PROCEDURETACE
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).
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months | Time interval from date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 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 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 |
| Tumor response | 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 | Defined as the proportion of patients achieving complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) according to mRECIST criteria. |
Countries
China
Outcome results
None listed