NCT07365930

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

Non-Interventional Study on the Benefits of Transjugular Intrahepatic Portosystemic Shunting in Patients With Hepatocellular Carcinoma Receiving Atezolizumab Plus Bevacizumab in First-Line Therapy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

While TIPS effectively treats CSPH in cirrhosis, its role in HCC patients receiving systemic therapy remains unclear. The NISTIPS TRITICC-4 study will investigate whether TIPS in patients receiving atezo+bev reduces portal hypertension-related complications and improves therapy outcomes. We hypothesize that TIPS is feasible in non-resectable HCC, lowers the risk of hepatic decompensation, and improves survival and treatment effectiveness by preserving liver function. Furthermore, an observational cohort study like NISTIPS TRITICC-4 offers an opportunity to evaluate the effectiveness, safety and tolerability of atezo+bev treatment with or without TIPS in a more heterogeneous patient population, by capturing data on treatment outcomes, quality of life, and safety in daily clinical practice. Moreover, it helps to identify patient subgroups, which may derive benefits or experience specific risks, helping to optimize personalized treatment strategies. The NISTIPS TRITICC-4 study is a prospective, multicentre, cohort study with associated accompanying research including archival tissue sample collection, which enrolls 350 patients 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 receiving atezolizumab + bevacizumab according to the market authorization.

Conditions

• Hepatocellular Carcinoma (HCC)

Timeline

• Start date: 2025-12-17
• Primary completion: 2031-12-17
• Completion: 2031-12-17
• First posted: 2026-01-26
• Last updated: 2026-02-05

Locations

1 site across 1 country: Germany