Liver shunt may boost outcomes in liver cancer patients on immunotherapy
NCT ID NCT07365930
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with advanced liver cancer who are starting a combination of two drugs (atezolizumab and bevacizumab). It will test if adding a procedure called TIPS (which places a small tube in the liver to improve blood flow) can help keep the liver working better for longer. The study will follow 350 participants to compare liver function, survival, and quality of life between those who get TIPS and those who do not.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 350 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospital of Düsseldorf
RECRUITINGDüsseldorf, North Rhine-Westphalia, 40225, Germany
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Other studies related to the condition(s) this trial covers.
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- Can a smart drug starve liver tumors without harming healthy tissue?
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- Can a new model forecast liver cancer in hepatitis b?