Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- HCC patients in atezo+bev treatment without TIPS
- description
- 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
- label
- HCC patients in atezo+bev treatment with TIPS
- description
- 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
Primary outcomes (1)
- measure
- Time to deterioration of liver function (TTDL)
- timeFrame
- up to 72 months
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. The patient is under 18 years of age at the time of giving signed informed consent. 3. The patient is unable to understand all implications of study participation.
References
Publications (0)
Data not yet available