NIS on the Benefits of TIPS in Patients With HCC Receiving Atezo+Bev in 1st-Line Therapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

350 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Lead sponsor

Roche Pharma AG

Collaborator

Heinrich-Heine University, Duesseldorf

Collaborator