本研究旨在評估 lenvatinib 與 pembrolizumab 聯合 TACE 對比 TACE 加上口服及靜脈注射（IV）安慰劑，在不可治癒、非轉移性肝細胞癌（HCC）患者中的療效與安全性。主要假設為 pembrolizumab 加 lenvatinib 聯合 TACE 在無惡化存活期（PFS）及整體存活期（OS）方面優於安慰劑加 TACE。
適應症：Carcinoma, Hepatocellular
收案條件
納入條件
- 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
排除條件
- 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
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。