Contrast-enhanced Computed Tomography Features of Microvascular Invasion Predict Response to Transarterial Chemoembolization Plus Tyrosine Kinase Inhibitor in Intermediate-stage Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- 未提供
研究组 & 干预措施
TACE group
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.
干预措施: TACE (Procedure)
TACE-TKI group
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.
干预措施: TKI (Drug)
TACE-TKI group
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.
干预措施: TACE (Procedure)
结局指标
主要结局
Overall survival
时间窗: 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
次要结局
- 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)
- 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)
研究者
Wenzhe Fan
Director
First Affiliated Hospital, Sun Yat-Sen University