Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Oslo, Norway.
Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Trials. 2021 Sep 20;22(1):642. doi: 10.1186/s13063-021-05587-w.
Colorectal cancer is one the most common cancers in the western world with increasing incidence. Approximately 50% of the patients develop liver metastases. Resection of liver metastases is the treatment of choice although almost half of the resected patients get recurrence in the liver.
The ASAC trial is a Scandinavian, multicentre, double-blinded, randomized, placebo-controlled study to determine whether adjuvant treatment with low-dose aspirin (acetylsalicylic acid (ASA)) can improve disease-free survival in patients treated for colorectal cancer liver metastases (CRCLM). Up to 800 patients operated for CRCLM will be randomized to Arm#1 ASA 160 mg once daily or Arm#2 Placebo, for a period of 3 years or until disease recurrence. The patients will be recruited at all major hepatobiliary surgical units in Norway, Sweden and Denmark and have follow-up according to standard of care and the National Guidelines.
The ASAC trial will be the first clinical interventional trial to assess the potential beneficial role of ASA in recurrence of CRCLM and survival. ASA is an inexpensive, well-tolerated and easily accessible drug that will be highly potential as adjuvant drug in secondary prevention of CRCLM if the study shows a beneficial effect. We will also determine the effect of ASA as adjuvant treatment on Health-Related Quality of Life and the cost-effectiveness.
ClinicalTrials.gov NCT03326791 . Registered on 31 October 2017.
结直肠癌是西方世界最常见的癌症之一，其发病率不断上升。大约 50%的患者会发展为肝转移。肝转移灶切除术是首选治疗方法，尽管近一半接受切除术的患者会在肝脏中复发。
ASAC 试验是一项斯堪的纳维亚多中心、双盲、随机、安慰剂对照研究，旨在确定低剂量阿司匹林（乙酰水杨酸（ASA））辅助治疗是否可以改善接受结直肠癌肝转移（CRCLM）治疗的患者的无病生存率。多达 800 名接受 CRCLM 手术的患者将被随机分为 ASA 160mg 组（每天一次）或安慰剂组（Arm#2），治疗期为 3 年或直至疾病复发。患者将在挪威、瑞典和丹麦的所有主要肝胆外科单位招募，并按照标准护理和国家指南进行随访。
ASAC 试验将是第一项评估 ASA 在 CRCLM 复发和生存中潜在有益作用的临床干预试验。ASA 是一种廉价、耐受性良好且易于获得的药物，如果研究显示出有益效果，它将成为 CRCLM 二级预防的潜在辅助药物。我们还将确定 ASA 作为辅助治疗对健康相关生活质量和成本效益的影响。
ClinicalTrials.gov NCT03326791。于 2017 年 10 月 31 日注册。
