本研究旨在评估 lenvatinib 与 pembrolizumab 联合 TACE 对比 TACE 加上口服及静脉注射（IV）安慰剂，在不可治愈、非转移性肝细胞癌（HCC）患者中的疗效与安全性。主要假设为 pembrolizumab 加 lenvatinib 联合 TACE 在无进展生存期（PFS）及总生存期（OS）方面优于安慰剂加 TACE。
适应症：Carcinoma, Hepatocellular
入组条件
纳入标准
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology
- Has HCC localized to the liver and not amenable to curative treatment
- Participants with Hepatitis C virus (HCV) are eligible if treatment was completed at least 1 month prior to starting study intervention
- Participants with Hepatitis B virus (HBV) are eligible
- Has adequately controlled blood pressure with or without antihypertensive medications
- Has adequate organ function
排除标准
- Is currently a candidate for liver transplantation
- Has had gastric bleeding within the last 6 months
- Has ascites that is not controlled with medication
- Has significant cardiovascular impairment within 12 months of the first dose of study intervention such as congestive heart failure
- Has a serious nonhealing wound, ulcer, or bone fracture
- Has received locoregional therapy to existing liver lesions
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。