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