The NISTIPS TRITICC-4 study is a prospective, multicentre, non-interventional cohort study to analyze the effectiveness of transjugular intrahepatic portosystemic shunting (TIPS) in patients with Hepatocellular carcinoma (HCC) receiving atezolizumab plus bevacizumab as first-line treatment. It will further characterize the effectiveness of atezolizumab and bevacizumab therapy, investigate post-market safety and evaluate health-related quality in HCC patient cohorts with or without TIPS in a real-world setting.
the presence of liver cirrhosis (cirrhosis confirmed by histology or liver stiffness or with unequivocal signs in ultrasound, endoscopy, and/or blood tests),
a disease that is not amenable to curative surgical and/or locoregional therapies, or a progressive disease after surgical and /or locoregional therapies,
A decision for treatment with atezolizumab + bevacizumab according to the market authorization with or without TIPS has been made before enrolling into the study by the treating physician.
The patient has not provided signed informed consent.
The patient is under 18 years of age at the time of giving signed informed consent.
The patient is unable to understand all implications of study participation.
The NISTIPS TRITICC-4 study enrolls participants in Germany of both sexes and ages over 18 years. Eligible patients are diagnosed with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) in 1st line therapy setting without (Analysis Cohort 1) or with (Analysis Cohort 2) TIPS.
Cohort
Prospective
Not listed
Time to deterioration of liver function (TTDL)
Time to deterioration of liver function (TTDL) is used as outcome measure to analyze the effectiveness of transjugular intrahepatic portosystemic shunting (TIPS) in patients with Hepatocellular carcinoma (HCC) receiving atezolizumab plus bevacizumab as first-line treatment in a real-world scenario. Liver function deterioration is registered if any of the following criteria was met for more than 4 weeks (\>28 days in a row): * Total bilirubin \> 2.0 x ULN OR \> 2.0 x baseline if baseline was abnormal * Alanine aminotransferase (ALT) AND aspartate aminotransferase (AST) \> 5x ULN OR \> 5.0 x baseline if baseline was abnormal * Alkaline phosphatase \>2.5x ULN OR \> 2.5 x baseline (if baseline was abnormal)
Overall survival (OS)
Overall survival (OS) is used as measurement to further characterize the effectiveness of atezolizumab and bevacizumab therapy in real-world HCC patient cohorts with or without TIPS.
Time on treatment (ToT)
Time on treatment (ToT), defined as duration from the first day of atezo+bev therapy to the day of the last dose of atezo+bev therapy
Prevalence of bleeding adverse events
Prevalence of bleeding adverse events post-administration of atezo+bev treatment
Overall Response Rate (ORR)
Overall Response Rate (ORR) defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR), as assessed by the investigator according to local protocol.
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Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead sponsor
Roche Pharma AG
Collaborator
Heinrich-Heine University, Duesseldorf
Collaborator
