Hepatobiliary Surgery Department, Guangxi Medical University Cancer Hospital, Nanning, China.
Hepatobiliary Surgery Department, the First People's Hospital of Qinzhou, Qinzhou, China.
Trials. 2024 Jan 5;25(1):25. doi: 10.1186/s13063-023-07742-x.
Entecavir and tenofovir disoproxil fumarate (TDF) are standard first-line treatments to prevent viral reactivation and hepatocellular carcinoma (HCC) in individuals chronically infected with the hepatitis B virus (HBV), but the long-term efficacy of the two drugs remains controversial. Also unclear is whether the drugs are effective at preventing viral reactivation or HCC recurrence after hepatectomy to treat HBV-associated HCC. This trial will compare recurrence-free survival, overall survival, viral indicators and adverse events in the long term between patients with HBV-associated HCC who receive entecavir or TDF after curative resection.
This study is a randomized, open-label trial. A total of 240 participants will be randomized 1:1 into groups receiving TDF or entecavir monotherapy. The two groups will be compared in terms of recurrence-free and overall survival at 1, 3, and 5 years after surgery; adverse events; virological response; rate of alanine transaminase normalization; and seroreactivity at 24 and 48 weeks after surgery.
This study will compare long-term survival between patients with HBV-associated HCC who receive TDF or entecavir monotherapy. Numerous outcomes related to prognosis will be analyzed and compared in this study.
ClinicalTrials.gov NCT02650271. Registered on January 7, 2016.
恩替卡韦和富马酸替诺福韦二吡呋酯（TDF）是预防乙型肝炎病毒（HBV）慢性感染者病毒再激活和肝细胞癌（HCC）的标准一线治疗药物，但这两种药物的长期疗效仍存在争议。也不清楚这两种药物在治疗 HBV 相关 HCC 的肝切除术后是否能有效预防病毒再激活或 HCC 复发。本试验将比较恩替卡韦或 TDF 治疗后根治性切除的 HBV 相关 HCC 患者的无复发生存、总生存、病毒指标和长期不良事件。
本研究为随机、开放标签试验。共 240 例患者将以 1:1 的比例随机分为 TDF 或恩替卡韦单药治疗组。两组将在术后 1、3、5 年分别比较无复发生存和总生存；不良事件；病毒学应答；丙氨酸转氨酶正常化率；以及术后 24 周和 48 周的血清学反应。
本研究将比较接受 TDF 或恩替卡韦单药治疗的 HBV 相关 HCC 患者的长期生存。本研究将分析和比较与预后相关的众多结局。
ClinicalTrials.gov NCT02650271。注册于 2016 年 1 月 7 日。
