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

NCT07365930 | Recruiting

• 2 other identifiers: NISTIPS TRITICC-4ML46195
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

HCC; TIPS; Tecentriq; Avastin; transjugular intrahepatic portosystemic shunting; Hepatocellular carcinoma; observational study; non-interventional study; Atezolizumab; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Time to deterioration of liver function (TTDL)

  Time to deterioration of liver function (TTDL) is used as outcome measure to analyze the effectiveness of transjugular intrahepatic portosystemic shunting (TIPS) in patients with Hepatocellular carcinoma (HCC) receiving atezolizumab plus bevacizumab as first-line treatment in a real-world scenario. Liver function deterioration is registered if any of the following criteria was met for more than 4 weeks (\>28 days in a row): * Total bilirubin \> 2.0 x ULN OR \> 2.0 x baseline if baseline was abnormal * Alanine aminotransferase (ALT) AND aspartate aminotransferase (AST) \> 5x ULN OR \> 5.0 x baseline if baseline was abnormal * Alkaline phosphatase \>2.5x ULN OR \> 2.5 x baseline (if baseline was abnormal)

  up to 72 months

Secondary Outcomes (8)

• Overall survival (OS)

  up to 72 months

• Time on treatment (ToT)

  up to 72 months

• Prevalence of bleeding adverse events

  up to 72 months

• Overall Response Rate (ORR)

  up to 72 months

• Time to New Extrahepatic Lesions or death due to any cause (TTNEL)

  up to 72 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• The patient has not provided signed informed consent.
• The patient is under 18 years of age at the time of giving signed informed consent.
• The patient is unable to understand all implications of study participation.

Sponsors & Collaborators

• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest: lead
• Roche Pharma AG: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator

Study Sites (1)

University Hospital of Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Christoph Roderburg, Professor

  Heinrich Heine University of Duesseldorf, University Hospital of Duesseldorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Roderburg, Professor

CONTACT

04969589978719; christoph.roderburg@med.uni-duesseldorf.de

Bianca Zaepf

CONTACT

04969589978778; zaepf.bianca@ikf-khnw.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 26, 2026
• Study Start: December 17, 2025
• Primary Completion (Estimated): December 17, 2031
• Study Completion (Estimated): December 17, 2031
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

DE (1)