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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. The patient has a histologically confirmed, locally advanced or metastatic and/or unresectable HCC with:
1. the presence of liver cirrhosis (cirrhosis confirmed by histology or liver stiffness or with unequivocal signs in ultrasound, endoscopy, and/or blood tests),
2. a disease that is not amenable to curative surgical and/or locoregional therapies, or a progressive disease after surgical and /or locoregional therapies,
2. 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.
NOTE: Patients who have already received 1-2 cycles of atezo+bev therapy are eligible for enrollment into the NISTIPS TRITICC-4 study, when the prescription of the medicine or other therapeutic strategies are clearly separated from the decision to include the patient in the study.
Exclusion Criteria:
1. The patient has not provided signed informed consent.
2. The patient is under 18 years of age at the time of giving signed informed consent.
3. The patient is unable to understand all implications of study participation.
Primary outcome measure(s)
Time to deterioration of liver function (TTDL) — up to 72 months 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)
Trial sites (1)
Facility
City
Region
Status
University Hospital of Düsseldorf
Düsseldorf
North Rhine-Westphalia
Recruiting
More Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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