RecruitingNot Applicable

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

Germany350 participantsStarted 2025-12-17

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. The patient has a histologically confirmed, locally advanced or metastatic and/or unresectable HCC with:
✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Time to deterioration of liver function (TTDL)

Timeframe: up to 72 months

Trial details

NCT IDNCT07365930

SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2031-12-17

Contact for this trial

Christoph Roderburg, Professor

04969589978719 christoph.roderburg@med.uni-duesseldorf.de

View on ClinicalTrials.gov More Hepatocellular Carcinoma (HCC) trials