TIPS benefits for people with hepatocellular carcinoma taking Tecentriq (atezolizumab) plus Avastin (bevacizumab) as first-line therapy.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

NISTIPS TRITICC-4 is a prospective, multicenter, non-interventional cohort in Germany enrolling about 350 adults with cirrhosis and locally advanced, metastatic, or unresectable HCC who are receiving atezolizumab plus bevacizumab. Patients are followed in two analysis cohorts depending on whether they have a transjugular intrahepatic portosystemic shunt (TIPS) or not, with collection of clinical outcomes, safety events, and health-related quality of life data in routine care. The study also includes archival tissue collection and aims to capture real-world tolerability and effectiveness of atezolizumab plus bevacizumab with or without TIPS. Data will be used to identify subgroups that may benefit or be at higher risk, helping inform personalized treatment choices.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospital of Düsseldorf
  Düsseldorf, North Rhine-Westphalia, Germany Recruiting

Study contacts

• Principal investigator: Christoph Roderburg, Professor — Heinrich Heine University of Duesseldorf, University Hospital of Duesseldorf
• Study coordinator: Christoph Roderburg, Professor
• Email: christoph.roderburg@med.uni-duesseldorf.de
• Phone: 04969589978719

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.