通过整合RECIST 1.1和α-胎蛋白（AFP）在第6周对肝细胞癌（HCC）使用抗血管生成治疗加免疫治疗的治疗反应进行评估，预测总生存期（OS）。本回顾性研究纳入了150例和214例接受组合治疗的HCC患者，分别在训练组和验证组中进行研究。收集了基线和第6周获得的医学影像和AFP水平。AFP反应分层：部分反应（PR）：AFP％≥75％下降；稳定性疾病（SD）：AFP％＜75％下降且≤10％升高；进展性疾病（PD）：AFP％＞10％升高。α-RECIST为：PR：RECIST 1.1-PR或AFP-PR；PD：AFP-PD或RECIST 1.1-PD且不满足AFP-PR；SD：既非PR也非PD。使用Kaplan-Meier曲线比较了OS。使用一致指数和基于时间的受试者工作特征曲线下面积评估了各种指标的预测能力。对于AFP＜20 ng/mL，RECIST 1.1在OS分层方面取得了显著成果（p=0.020）。对于AFP≥20 ng/mL，与RECIST 1.1、mRECIST和AFP反应相比，α-RECIST在C指数方面表现更好（0.73 vs 0.66 vs 0.68 vs 0.69）。国家癌症中心（NCC）策略在AFP＜20 ng/mL的情况下使用RECIST 1.1，在AFP≥20 ng/mL的情况下使用α-RECIST，并且在C指数方面表现更好（0.73 vs 0.67 vs 0.69 vs 0.64）。在验证组中证实了α-RECIST和NCC策略的表现（C指数=0.77和0.74）。相比于RECIST 1.1、mRECIST和AFP反应，α-RECIST和NCC策略在AFP≥20 ng/mL组和整个队列中取得了更好的生存分层表现。α-RECIST和国家癌症中心策略是确定抗血管生成治疗加免疫治疗的治疗反应和在AFP≥20 ng/mL组和整个队列中进行准确预后分层的最佳方法，有助于肿瘤学家在6周时早期识别反应者和进展，并进行临床决策。• RECIST 1.1适用于基线α-胎蛋白（AFP）＜20 ng/mL的患者。• 对于基线AFP≥20 ng/mL的患者，整合RECIST 1.1和AFP反应（α-RECIST）可能有助于在使用其他有效药物之前早期识别生存益处和进展定义。• 国家癌症中心策略是基于基线AFP水平确定抗血管生成治疗和免疫治疗的治疗反应的最佳分层策略。© 2023该作者在European Society of Radiology的独家许可下。

To assess the therapeutic response of HCC to antiangiogenic therapy plus immunotherapy by integrating RECIST 1.1 and alpha-fetoprotein (AFP) response at the 6th week to predict overall survival (OS).This retrospective study included 150 and 214 patients with HCC who received combination therapy in training and validation cohorts. The medical images and AFP levels obtained at baseline and 6th week were collected. AFP response stratification: partial response (PR): AFP% ≥ 75% decline; stable disease (SD): AFP% < 75% decline and  ≤ 10% elevation; progressive disease (PD): AFP% > 10% elevation. The alpha-RECIST was: PR: RECIST 1.1-PR or AFP-PR; PD: AFP-PD or RECIST 1.1-PD and does not satisfy AFP-PR; SD: neither PR nor PD. OS was compared using Kaplan-Meier curves. The predictive ability of various criteria was evaluated using the concordance index and time-dependent area under the receiver-operating characteristic curve.RECIST 1.1 achieved significant OS stratification (p = 0.020) for AFP < 20 ng/mL. For AFP ≥ 20 ng/mL, alpha-RECIST showed better performance than RECIST 1.1, mRECIST, and AFP response according to C-index (0.73 vs 0.66 vs 0.68 vs 0.69). The National Cancer Center (NCC) strategy utilized RECIST 1.1 for AFP < 20 ng/mL and alpha-RECIST for AFP ≥ 20 ng/mL and showed better performance than RECIST 1.1, mRECIST and AFP response according to C-index (0.73 vs 0.67 vs 0.69 vs 0.64). The performances of alpha-RECIST and NCC Strategy were confirmed in the validation cohort (C-index = 0.77 and 0.74).The alpha-RECIST and NCC Strategy achieved better survival stratification in patients with HCC under combination therapy in the AFP ≥ 20 ng/mL group and the whole cohort compared to the RECIST 1.1, mRECIST, and AFP response.The alpha-RECIST and National Cancer Center strategy are optimal methods for determining therapeutic response to a combination of anti-angiogenic therapy plus immunotherapy and facilitating accurate prognostic stratification for HCC in the AFP ≥ 20 ng/mL group and the whole cohort, which may help oncologists for early identification of responders and progression at 6 weeks and clinical decision-making.• RECIST 1.1 is indicated for patients with baseline alpha-fetoprotein (AFP) < 20 ng/mL. • For patients with baseline AFP ≥ 20 ng/mL, integrating RECIST 1.1 and AFP response (alpha-RECIST) may aid in the early identification of survival benefits and progression definition prior to the administration of additional efficacious drugs. • The National Cancer Center strategy is an optimal stratified strategy for determining therapeutic response to a combination of anti-angiogenic therapy and immunotherapy for HCC based on baseline AFP levels.© 2023. The Author(s), under exclusive licence to European Society of Radiology.