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Recruiting NCT07365930

NCT07365930 NIS on the Benefits of TIPS in Patients With HCC Receiving Atezo+Bev in 1st-Line Therapy

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Clinical Trial Summary
NCT ID NCT07365930
Status Recruiting
Phase
Sponsor Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Condition Hepatocellular Carcinoma (HCC)
Study Type OBSERVATIONAL
Enrollment 350 participants
Start Date 2025-12-17
Primary Completion 2031-12-17

Trial Parameters

Condition Hepatocellular Carcinoma (HCC)
Sponsor Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study Type OBSERVATIONAL
Phase N/A
Enrollment 350
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-12-17
Completion 2031-12-17

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Brief 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.

Eligibility Criteria

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.

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