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Идёт набор NCT07365930

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

— Наблюдательное Hepatocellular Carcinoma (HCC)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Hepatocellular Carcinoma (HCC). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
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Официальное название

Non-Interventional Study on the Benefits of Transjugular Intrahepatic Portosystemic Shunting in Patients With Hepatocellular Carcinoma Receiving Atezolizumab Plus Bevacizumab in First-Line Therapy

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Time to deterioration of liver function (TTDL) [Срок оценки: up to 72 months]
Вторичные конечные точки (8)
  • Overall survival (OS) [Срок оценки: up to 72 months]
  • Time on treatment (ToT) [Срок оценки: up to 72 months]
  • Prevalence of bleeding adverse events [Срок оценки: up to 72 months]
  • Overall Response Rate (ORR) [Срок оценки: up to 72 months]
  • Time to New Extrahepatic Lesions or death due to any cause (TTNEL) [Срок оценки: up to 72 months]
  • Post-market safety of atezolizumab plus bevacizumab [Срок оценки: up to 72 months]
  • Proportion of patients with improved, maintained, or worsened Health-Related Quality of Life (HR-QoL) according to EORTC QLQ-C30 and QLQ-HCC18 assessment [Срок оценки: up to 72 months]
  • Time to HR-QoL Deterioration (HR-QoL TTD) derived from EORTC QLQ-C30 and QLQ-HCC18 assessment [Срок оценки: up to 72 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • University Hospital of Düsseldorf — Düsseldorf

Идентификаторы

NCT: NCT07365930 · NISTIPS TRITICC-4 · ML46195

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗