为了描述当代肾细胞癌（RCC）试验中资格标准的限制性，使用美国临床肿瘤学会（ASCO）——癌症研究友人协会（FCR）倡议所提出的建议。鉴定了在2012年6月30日至2022年6月30日期间开始评估RCC患者系统性治疗的I-III期试验。鉴定了关于脑转移、先前或同时存在的恶性肿瘤、乙型肝炎病毒（HBV）或丙型肝炎病毒（HCV）感染，以及人类免疫缺陷病毒（HIV）感染的资格标准，并分为三组：排除、有条件包括和未报告。描述性统计分析用于确定资格标准的频率。使用Fischer精确检验或卡方检验计算其与某些试验特征的相关性。最初鉴定了423个RCC试验，其中112个（26.5%）有足够可获取的信息。排除HIV感染、HBV/HCV感染、脑转移和先前或同时存在的恶性肿瘤的患者分别在74.1%、53.6%、33.0%和8.0%的试验中被报告。在HIV和HBV/HCV感染的背景下，很大程度上排除了参与免疫疗法评估的患者（分别为94.4%和77.8%）。此外，在评估靶向治疗（36.4%）、联合治疗（33.3%）和免疫疗法（22.2%）的试验中，脑转移也被排除在外。排除先前或同时存在的恶性肿瘤的患者的情况较少报告，分别占目标治疗、联合治疗和免疫疗法试验的9.1%、8.3%和5.6%。相当比例的RCC试验采用限制性的资格标准，排除了患有相当普遍的共病症的患者。实施ASCO-FCR的建议将确保得到的数据更具包容性，并与实际临床患者群体相一致。本文受版权保护，禁止复制。

To characterize the restrictiveness of eligibility criteria in contemporary renal cell carcinoma (RCC) trials, using recommendations from the American Society of Clinical Oncology (ASCO)-Friends of Cancer Research (FCR) initiative.Phase I-III trials assessing systemic therapies in patients with RCC starting between June 30, 2012 and June 30, 2022 were identified. Eligibility criteria regarding brain metastases, prior or concurrent malignancies, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, and human immunodeficiency virus (HIV) infection were identified and stratified into 3 groups: exclusion, conditional inclusion, and not reported. Descriptive statistics were used to determine the frequency of eligibility criteria. The Fischer's exact test or Chi-square test were performed to calculate their associations with certain trial characteristics.423 RCC trials were initially identified of which 112 (26.5%) had sufficient accessible information. Exclusion of patients with HIV infection, HBV/HCV infection, brain metastases, and prior or concurrent malignancies were reported in 74.1%, 53.6%, 33.0%, and 8.0% of trials, respectively. In the context of HIV and HBV/HCV infection, patients were largely excluded from trials evaluating immunotherapy (94.4% and 77.8%, respectively). In addition, brain metastases were excluded in trials assessing targeted therapy (36.4%), combination therapy (33.3%), and immunotherapy (22.2%). Exclusion of patients with prior or concurrent malignancies was less frequently reported, accounting for 9.1%, 8.3%, and 5.6% targeted, combination and immunotherapy trials, respectively.A substantial proportion of RCC trials utilize restrictive eligibility criteria, excluding patients with fairly prevalent comorbidities. Implementing the ASCO-FCR recommendations will ensure resulting data is more inclusive and aligned with patient populations in the real-world.This article is protected by copyright. All rights reserved.