Future oncology (London, England) · 2026
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).
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Angendohr Carolin, Weigel Christian, Kunstein Anselm, Joerdens Markus, Goetze Thorsten, Al-Batran Salah-Eddin, Zäpf Bianca, Gonzalez-Carmona Maria, Sahin Cennet, Berres Marie-Luise, Foerster Friedrich, Ben Khaled Najib, Koch Christine, Kandulski Arne, Wege Henning, Trebicka Jonel, Jochheim Leonie S, Dill Michael T, Springfeld Christoph, Daum Severin, Treese Christoph, Ehmer Ursula, Luedde Tom, Bode Johannes, Roderburg Christoph
Аннотация
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.
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.