Study protocol of a prospective, non-interventional cohort study evaluating the benefits of transjugular intrahepatic portosystemic shunt in patients with hepatocellular carcinoma receiving first-line atezolizumab plus bevacizumab (NISTIPS TRITICC-4, IKF092).

IF 3.1 4区医学 Q2 ONCOLOGY

Future oncology Pub Date : 2026-10-20 DOI:10.1080/14796694.2026.2748246

Carolin Angendohr, Christian Weigel, Anselm Kunstein, Markus Joerdens, Thorsten Goetze, Salah-Eddin Al-Batran, Bianca Zäpf, Maria Gonzalez-Carmona, Cennet Sahin, Marie-Luise Berres, Friedrich Foerster, Najib Ben Khaled, Christine Koch, Arne Kandulski, Henning Wege, Jonel Trebicka, Leonie S Jochheim, Michael T Dill, Christoph Springfeld, Severin Daum, Christoph Treese, Ursula Ehmer, Tom Luedde, Johannes Bode, Christoph Roderburg

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引用次数: 0

Abstract

Background: Hepatocellular carcinoma (HCC) is a leading cause of cancer-related mortality, with most patients diagnosed at an advanced stage. Atezolizumab plus bevacizumab is a current standard first-line therapy; however, outcomes are strongly influenced by underlying cirrhosis and clinically significant portal hypertension (CSPH). Complications such as ascites and variceal bleeding may limit treatment continuation, particularly as bevacizumab increases bleeding risk. Transjugular intrahepatic portosystemic shunt (TIPS) reduces portal pressure and may improve outcomes, but its role in patients receiving immunoncology-based systemic therapy remains unclear.

Methods: NISTIPS TRITICC-4 is a prospective, multicentre, non-interventional cohort study conducted at up to 25 centers in Germany. A total of 350 adult patients with cirrhosis and unresectable or metastatic HCC receiving first-line atezolizumab plus bevacizumab will be enrolled. Patients are allocated to two cohorts: TIPS in situ plus atezolizumab and bevacizumab or atezolizumab plus bevacizumab alone, according to routine clinical practice.The primary endpoint is time to deterioration of liver function (TTDL), defined as persistent worsening of liver parameters for >4 weeks. Secondary endpoints include overall survival, time on treatment, overall response rate, time to new extrahepatic lesions or death, and safety with focus on bleeding and TIPS-related complications.Time-to-event endpoints will be analyzed using Kaplan-Meier methods and Cox models. Propensity score matching will be applied to adjust for confounding. Analyses are exploratory.

Discussion: This study will provide real-world evidence on the impact of TIPS in HCC patients receiving atezolizumab plus bevacizumab and may support more individualized management strategies in this high-risk population.

Clinical trial registration: www.clinicaltrials.gov identifier is NCT07365930.

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一项前瞻性、非介入性队列研究的研究方案，评估接受一线阿特唑单抗+贝伐单抗治疗的肝癌患者经颈静脉肝内门静脉系统分流术的益处。

背景：肝细胞癌（HCC）是癌症相关死亡的主要原因，大多数患者诊断为晚期。Atezolizumab +贝伐单抗是目前标准的一线治疗；然而，潜在的肝硬化和临床显著的门脉高压（CSPH）对结果有很大影响。腹水和静脉曲张出血等并发症可能限制治疗的继续，特别是贝伐单抗增加出血风险。经颈静脉肝内门静脉系统分流术（TIPS）可降低门静脉压力并改善预后，但其在接受基于免疫肿瘤的全身治疗的患者中的作用尚不清楚。NISTIPS TRITICC-4是一项在德国多达25个中心进行的前瞻性、多中心、非干预性队列研究。共有350名肝硬化和不可切除或转移性HCC的成年患者接受一线atezolizumab加贝伐单抗治疗。根据常规临床实践，患者被分配到两个队列：TIPS原位加atezolizumab和贝伐单抗或atezolizumab加贝伐单抗单独。主要终点是肝功能恶化的时间（TTDL），定义为肝脏参数持续恶化4周。次要终点包括总生存期、治疗时间、总缓解率、发生新肝外病变或死亡的时间，以及以出血和tips相关并发症为重点的安全性。将使用Kaplan-Meier方法和Cox模型分析时间到事件端点。倾向得分匹配将用于调整混杂。分析是探索性的。讨论：该研究将为TIPS对接受atezolizumab + bevacizumab治疗的HCC患者的影响提供真实证据，并可能支持在这一高危人群中采用更个性化的管理策略。临床试验注册：www.clinicaltrials.gov标识符：NCT07365930。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Future oncology ONCOLOGY-

CiteScore

5.40

自引率

3.00%

发文量

335

审稿时长

4-8 weeks

期刊介绍： Future Oncology (ISSN 1479-6694) provides a forum for a new era of cancer care. The journal focuses on the most important advances and highlights their relevance in the clinical setting. Furthermore, Future Oncology delivers essential information in concise, at-a-glance article formats - vital in delivering information to an increasingly time-constrained community. The journal takes a forward-looking stance toward the scientific and clinical issues, together with the economic and policy issues that confront us in this new era of cancer care. The journal includes literature awareness such as the latest developments in radiotherapy and immunotherapy, concise commentary and analysis, and full review articles all of which provide key findings, translational to the clinical setting.