Набор скоро начнётся NCT07449637

Real-World Treatment Patterns and Survival Outcomes in Patients With Intermediate-Stage Hepatocellular Carcinoma.

— Наблюдательное BCLC Stage B Hepatocellular Carcinoma

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: BCLC Stage B Hepatocellular Carcinoma. 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: Египет
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Real-World Treatment Patterns and Survival Outcomes in Patients With Intermediate-Stage Hepatocellular Carcinoma: An Observational Cohort Study.

Обзор

The goal of this observational study is to learn about the different treatment options for intermediate-stage hepatocellular carcinoma. The main question it aims to answer is: \- What are the survival outcomes among participants aged 18 or older who receive treatment for intermediate-stage hepatocellular carcinoma?

Подробное описание

Aim of work:

\- To evaluate real-world treatment patterns and survival outcomes among patients with intermediate-stage hepatocellular carcinoma (BCLC-B) treated at a tertiary care center.

Study Design:

\- Observational cohort study.

Study Setting:

\- Single-center study at Sohag Oncology Center.

Study Period:

\- 01 January 2020 - 31 December 2025.

Sample Size:

* Expected cohort: 120-300 patients. * Adequate for survival analysis and multivariable modeling in real-world studies.

Data Collection

1. Baseline Characteristics:

* Age, sex * Etiology of liver disease (HBV, HCV, MASH, …) * AFP level * Child-Pugh score * ALBI grade * Tumor burden (number, size of largest lesion, bilobar involvement) 2. Treatment Variables

* Type of initial therapy * Number of TACE sessions * Time to TACE refractoriness * Use of systemic therapy (Tyrosine Kinase inhibitors, Immunotherapy, combinations) * Treatment sequencing

Statistical analysis:

* Statistical analysis will be performed by SPSS 24.0 software (SPSS, Inc., Chicago, IL). * Descriptive statistics for baseline characteristics. * Kaplan-Meier survival curves for OS and PFS. * Log-rank test for group comparisons. * Multivariable Cox proportional hazards regression to identify predictors of survival. * Subgroup analyses:

* Up-to-7 in vs out. * Child-Pugh A vs B. * TACE-only vs sequential/systemic.

Study Objectives:

1. Primary Objective

\- To estimate overall survival (OS) among patients with intermediate-stage HCC receiving real-world treatment. 2. Secondary Objectives

* To describe real-world treatment patterns (First-line, subsequent lines, combination therapies) and time to treatment changes. * To estimate progression-free survival (PFS) and time to treatment failure (TTF) by treatment group. * To evaluate safety signals (hospitalizations for treatment-related complications) in each treatment group. * To identify predictors of survival, including:

* Tumor burden. * Child-Pugh class. * Laboratory markers (AFP, Bilirubin, Albumin).

Первичные конечные точки

Overall Survival (OS) [Срок оценки: From randomization to the end of treatment at 5 years.]
Progression-Free Survival (PFS) [Срок оценки: From randomization to the end of treatment at 5 years.]
Objective response (mRECIST) [Срок оценки: From randomization to the end of treatment at 5 years.]
Adverse events (CTCAE) [Срок оценки: From randomization to the end of treatment at 5 years.]

Критерии участия

Критерии включения

Aged ≥18 years.
Both sexes.
Diagnosis of hepatocellular carcinoma based on accepted radiologic or histologic criteria.
Classified as intermediate stage (BCLC-B) at time of decision for first-line treatment.
Child-Pugh A or B.
ECOG performance status 0-1.