传输：利用有癌症病史的捐赠者的废弃肝脏来治疗缺乏标准分配的患者-一项同情性使用探索性研究

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-02-22 DOI:10.1016/j.conctc.2025.101465

Dominik Thomas Koch , Malte Schirren , Severin Jacobi , Christian Lange , Jens Werner , Dionysios Koliogiannis , Markus Guba

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引用次数: 0

摘要

背景：由于供体的潜在恶性肿瘤，大量存活的供体肝脏被丢弃。同时，某些肝脏恶性肿瘤患者，如不可切除的结直肠癌肝转移（CRC-LM），不可切除的肝内或肝门周围胆管癌（iCCC/phCCC），或免疫治疗应答的不可切除的肝细胞癌（HCC），往往面临较差的生存结果，被认为不符合潜在治愈性肝移植的条件。在这种情况下，合理的风险-收益分析表明，对于这些面临短期致命后果的患者来说，移植具有理论上肿瘤传播风险的器官可能是合理的。方法：TRANSMIT研究是一项同情性使用探索性研究，旨在评估目前或过去有癌症病史的个体供体器官用于不符合常规器官分配条件的肝恶性肿瘤（CRC-LM, i/phCCC， HCC）患者肝移植的有效性和安全性。该研究将评估供体器官的利用率，否则将被丢弃，总生存期，无进展生存期，以及1年和3年的肿瘤传播率，按适应症分层。来自目前或过去有癌症病史的个体的供体器官可能是扩大有限供体库的一种有价值和安全的资源，特别是对于缺乏标准器官分配的患者。

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TRANSMIT: Utilizing discarded livers from donors with a history of cancer for patients lacking access to standard allocation - A compassionate use exploratory study

Background

A substantial number of viable donor livers are discarded due to the donor's underlying malignancy. Concurrently, patients with certain liver malignancies – such as unresectable colorectal cancer liver metastases (CRC-LM), unresectable intrahepatic or perihilar cholangiocarcinoma (iCCC/phCCC), or unresectable hepatocellular carcinoma (HCC) responding to immunotherapy – often face poor survival outcomes and are deemed ineligible for potentially curative liver transplantation. In this context, a rational risk-benefit analysis suggests that transplanting an organ with a theoretical risk of tumor transmission may be justifiable for these patients facing otherwise short-term fatal outcomes.

Methods

The TRANSMIT study is a compassionate use exploratory study aimed at assessing the utility and safety of using donor organs from individuals with a current or past history of cancer for liver transplantation in patients with liver malignancies (CRC-LM, i/phCCC, HCC) who are not eligible for regular organ allocation. The study will evaluate the utilization rate of donor organs that would otherwise be discarded, overall survival, progression-free survival, and tumor transmission rates at one and three years, stratified by indication.

Discussion

Donor organs from individuals with a current or past history of cancer may represent a valuable and safe resource for expanding the limited donor pool, particularly for patients who lack access to standard organ allocation.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.