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

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Status: Enrolling

Conditions: Hepatocellular Carcinoma (HCC)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07365930

ML46195 (Other Identifier)

NISTIPS TRITICC-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

350 participants in 2 patient groups

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

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