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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
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The patient has a histologically confirmed, locally advanced or metastatic and/or unresectable HCC with:

‣ the presence of liver cirrhosis (cirrhosis confirmed by histology or liver stiffness or with unequivocal signs in ultrasound, endoscopy, and/or blood tests),

⁃ a disease that is not amenable to curative surgical and/or locoregional therapies, or a progressive disease after surgical and /or locoregional therapies,

• 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.

Locations
Other Locations
Germany
University Hospital of Düsseldorf
RECRUITING
Düsseldorf
Contact Information
Primary
Christoph Roderburg, Professor
christoph.roderburg@med.uni-duesseldorf.de
04969589978719
Backup
Bianca Zaepf
zaepf.bianca@ikf-khnw.de
04969589978778
Time Frame
Start Date: 2025-12-17
Estimated Completion Date: 2031-12-17
Participants
Target number of participants: 350
Treatments
HCC patients in atezo+bev treatment without TIPS
Out of 350 HCC patients 168 patients with histologically confirmed, locally advanced or metastatic and/or unresectable liver cancer, without prior transjugular intrahepatic portosystemic shunting and receiving atezolizumab + bevacizumab treatment, will be assigned to analysis cohort 1: HCC patients in atezo+bev treatment without TIPS
HCC patients in atezo+bev treatment with TIPS
Out of 350 HCC patients 182 patients with histologically confirmed, locally advanced or metastatic and/or unresectable liver cancer, with prior transjugular intrahepatic portosystemic shunting and receiving atezolizumab + bevacizumab treatment, will be assigned to analysis cohort 1: HCC patients in atezo+bev treatment with TIPS
Related Therapeutic Areas
Sponsors
Collaborators: Heinrich-Heine University, Duesseldorf, Roche Pharma AG
Leads: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

This content was sourced from clinicaltrials.gov