Transplant Institute, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.
Sahlgrenska University Hospital, Gothenburg, Sweden.
Trials. 2022 Sep 30;23(1):831. doi: 10.1186/s13063-022-06778-9.
Around one fourth of patients with colorectal cancer present themselves with distant metastases at the time of diagnosis, and one additional one fifth of the patients will develop distant metastases during the disease, most commonly in the liver. Surgical treatment such as liver resection or ablation, often combined with chemotherapy and targeted therapy, is the only treatment option with curative potential, but only about 20% of the patients with liver metastases are candidates for surgical intervention. Standard treatment for unresectable patients is palliative oncological therapy; however, less than 10% of these patients will achieve a 5-year survival. Non-randomized studies indicate that liver transplantation could be an option for selected patients with colorectal liver metastases (CRLM), which are not suitable for operation or ablation due to surgical technical reasons such as massive tumor burden and small future liver remnant, or oncological reasons, for example, early relapse after liver surgery. Since there is a shortage of donated liver grafts, it is important to select the patient group that benefit most from the treatment. Although some studies present positive results from liver transplantation of CRLM, the results must be validated in a randomized controlled trial before this new indication for liver transplantation can be introduced as a clinical routine.
The SOULMATE study is a randomized study evaluating if liver transplantation with liver grafts, primarily from extended criteria donors, increases overall survival in patients with CRLM, not suitable for resection or ablation, in comparison with best established treatment. Patients will be randomized to liver transplantation (LT)+ best established treatment (BET) or to best established treatment only. In the SOULMATE trial, we will evaluate the use of livers from extended criteria donors to decrease the risk of prolonging waiting time for patients on the waiting list for LT.
The SOULMATE study has the possibility to confirm the positive results of previous studies in a randomized setting. The use of extended criteria donors will make the results transferable globally, as most countries are struggling with organ shortage.
Clinical Trial number: NCT04161092 registered 13 November 2019.
大约四分之一的结直肠癌患者在诊断时就已经出现远处转移，另有五分之一的患者在疾病过程中会发生远处转移，最常见的转移部位是肝脏。手术治疗（如肝切除术或消融术），通常联合化疗和靶向治疗，是唯一具有治愈潜力的治疗选择，但只有约 20%的肝转移患者适合手术干预。无法切除患者的标准治疗是姑息性肿瘤治疗；然而，这些患者中不到 10%的患者能达到 5 年生存率。非随机研究表明，对于由于大量肿瘤负荷和小的未来肝残余等手术技术原因或肿瘤学原因（例如，肝手术后早期复发）而不适合手术或消融的结直肠肝转移（CRLM）患者，肝移植可能是一种选择。由于捐献的肝移植物短缺，选择最能从治疗中获益的患者群体非常重要。尽管一些研究报告了 CRLM 肝移植的阳性结果，但在将这一新的肝移植适应证引入临床常规之前，需要在随机对照试验中验证这些结果。
SOULMATE 研究是一项随机研究，评估原发性来源于扩展标准供体的肝移植物的肝移植是否会增加不适合切除或消融的 CRLM 患者的总生存率，与最佳现有治疗相比。患者将被随机分配到肝移植（LT）+最佳现有治疗（BET）或仅接受最佳现有治疗。在 SOULMATE 试验中，我们将评估使用扩展标准供体的肝脏来降低 LT 等待名单上患者等待时间延长的风险。
SOULMATE 研究有可能在随机环境中证实以前研究的阳性结果。使用扩展标准供体将使结果在全球范围内具有可转移性，因为大多数国家都在与器官短缺作斗争。
临床试验编号：NCT04161092，于 2019 年 11 月 13 日注册。
