TIPS benefits for people with hepatocellular carcinoma taking Tecentriq (atezolizumab) plus Avastin (bevacizumab) as first-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
This study will try to see if placing a TIPS device helps people with advanced or unresectable hepatocellular carcinoma who are starting first-line treatment with Tecentriq plus Avastin.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Academic / other |
| Drugs / interventions | atezolizumab, bevacizumab |
| Locations | 1 site (Düsseldorf, North Rhine-Westphalia) |
| Trial ID | NCT07365930 on ClinicalTrials.gov |
What this trial studies
NISTIPS TRITICC-4 is a prospective, multicenter, non-interventional cohort in Germany enrolling about 350 adults with cirrhosis and locally advanced, metastatic, or unresectable HCC who are receiving atezolizumab plus bevacizumab. Patients are followed in two analysis cohorts depending on whether they have a transjugular intrahepatic portosystemic shunt (TIPS) or not, with collection of clinical outcomes, safety events, and health-related quality of life data in routine care. The study also includes archival tissue collection and aims to capture real-world tolerability and effectiveness of atezolizumab plus bevacizumab with or without TIPS. Data will be used to identify subgroups that may benefit or be at higher risk, helping inform personalized treatment choices.
Who should consider this trial
Good fit: Adults (over 18) with cirrhosis and locally advanced, metastatic, or unresectable HCC who are starting or have just started first-line treatment with atezolizumab plus bevacizumab and for whom a decision about TIPS has been made are ideal candidates.
Not a fit: People without cirrhosis or portal hypertension, those eligible for curative surgery or locoregional cures, or patients with contraindications to TIPS are unlikely to benefit from this TIPS-focused comparison.
Why it matters
Potential benefit: If successful, adding TIPS could reduce portal-hypertension complications, help preserve liver function, and allow patients to remain on systemic therapy longer, which may improve survival and quality of life.
How similar studies have performed: TIPS is an established treatment for portal hypertension in cirrhosis, but its specific benefit in HCC patients receiving atezolizumab plus bevacizumab has not been well tested in prospective real-world cohorts.
Eligibility criteria
Show full inclusion / exclusion 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. 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.
Where this trial is running
Düsseldorf, North Rhine-Westphalia
- University Hospital of Düsseldorf — Düsseldorf, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Christoph Roderburg, Professor — Heinrich Heine University of Duesseldorf, University Hospital of Duesseldorf
- Study coordinator: Christoph Roderburg, Professor
- Email: christoph.roderburg@med.uni-duesseldorf.de
- Phone: 04969589978719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.